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1.
Expert Rev Clin Pharmacol ; 14(2): 211-224, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33464138

RESUMO

INTRODUCTION: Norgestimate (NGM) is a testosterone derivative with peculiar receptor activities. AREAS COVERED: This is a narrative review of the available data on the pharmacotherapy of NGM in combined hormonal contraceptives (CHCs) in terms of contraceptive efficacy, venous thromboembolism (VTE) risk, safety, tolerability and bleeding patterns. A comprehensive literature review was conducted in August 2020 using PubMed with the keyword 'norgestimate'. EXPERT OPINION: NGM shows a mild estrogenic activity associated with anti-mineralocorticoid and anti-androgenic properties, largely responsible for the cardiovascular safety profile. The anti-androgenic property depends on the androgen receptor (AR) nuclear translocation (AR trafficking and its subnuclear distribution), the inhibition of 5α-reductase activity (it possesses higher activity compared to other available progestins), and the increase on sexual hormone binding globulin (SHBG) levels if combined with an estrogenic counterpart. NGM is one of the molecules that best modulates the power of ethinyl-estradiol on the thromboembolic risk, being associated with the lowest VTE risk between different CHCs. NGM has the advantage of retaining peripheral anti-androgenic activity, demonstrated by the impact on lipid and glucose metabolism, and it should be preferred if compared with other similar progestins of the same class of risk which are much more androgenic, such as levonorgestrel.


Assuntos
Contraceptivos Hormonais/administração & dosagem , Norgestrel/análogos & derivados , Tromboembolia Venosa/induzido quimicamente , Animais , Contraceptivos Hormonais/efeitos adversos , Contraceptivos Hormonais/farmacologia , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Levanogestrel/farmacologia , Norgestrel/administração & dosagem , Norgestrel/efeitos adversos , Norgestrel/farmacologia , Risco , Tromboembolia Venosa/epidemiologia
2.
Cochrane Database Syst Rev ; 12: CD007245, 2020 12 21.
Artigo em Inglês | MEDLINE | ID: mdl-33348436

RESUMO

BACKGROUND: Adjuvant tamoxifen reduces the risk of breast cancer recurrence in women with oestrogen receptor-positive breast cancer. Tamoxifen also increases the risk of postmenopausal bleeding, endometrial polyps, hyperplasia, and endometrial cancer. The levonorgestrel-releasing intrauterine system (LNG-IUS) causes profound endometrial suppression. This systematic review considered the evidence that the LNG-IUS prevents the development of endometrial pathology in women taking tamoxifen as adjuvant endocrine therapy for breast cancer. OBJECTIVES: To determine the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in pre- and postmenopausal women taking adjuvant tamoxifen following breast cancer for the outcomes of endometrial and uterine pathology including abnormal vaginal bleeding or spotting, and secondary breast cancer events. SEARCH METHODS: We searched the following databases on 29 June 2020; The Cochrane Gynaecology and Fertility Group specialised register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and Cumulative Index to Nursing and Allied Health Literature. We searched the Cochrane Breast Cancer Group specialised register on 4 March 2020. We also searched two trials registers, checked references for relevant trials and contacted study authors and experts in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of women with breast cancer on adjuvant tamoxifen that compared the effectiveness of the LNG-IUS with endometrial surveillance versus endometrial surveillance alone on the incidence of endometrial pathology. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary outcome measure was endometrial pathology (including polyps, endometrial hyperplasia, or endometrial cancer), diagnosed at hysteroscopy or endometrial biopsy. Secondary outcome measures included fibroids, abnormal vaginal bleeding or spotting, breast cancer recurrence, and breast cancer-related deaths. We rated the overall certainty of evidence using GRADE methods. MAIN RESULTS: We included four RCTs (543 women analysed) in this review. We judged the certainty of the evidence to be moderate for all of the outcomes, due to imprecision (i.e. limited sample sizes and low event rates). In the included studies, the active treatment arm was the 20 µg/day LNG-IUS plus endometrial surveillance; the control arm was endometrial surveillance alone. In tamoxifen users, the LNG-IUS probably reduces the incidence of endometrial polyps compared to the control group over both a 12-month period (Peto odds ratio (OR) 0.22, 95% confidence interval (CI) 0.08 to 0.64, I² = 0%; 2 RCTs, n = 212; moderate-certainty evidence) and over a long-term follow-up period (24 to 60 months) (Peto OR 0.22, 95% CI 0.13 to 0.39; I² = 0%; 4 RCTs, n = 417; moderate-certainty evidence). For long-term follow-up, this suggests that if the incidence of endometrial polyps following endometrial surveillance alone is assumed to be 23.5%, the incidence following LNG-IUS with endometrial surveillance would be between 3.8% and 10.7%.  The LNG-IUS probably slightly reduces the incidence of endometrial hyperplasia compared with controls over a long-term follow-up period (24 to 60 months) (Peto OR 0.13, 95% CI 0.03 to 0.67; I² = 0%; 4 RCTs, n = 417; moderate-certainty evidence). This suggests that if the chance of endometrial hyperplasia following endometrial surveillance alone is assumed to be 2.8%, the chance following LNG-IUS with endometrial surveillance would be between 0.1% and 1.9%. However, it should be noted that there were only six cases of endometrial hyperplasia. There was insufficient evidence to reach a conclusion regarding the incidence of endometrial cancer in tamoxifen users, as no studies reported cases of endometrial cancer. At 12 months of follow-up, the LNG-IUS probably increases abnormal vaginal bleeding or spotting compared to the control group (Peto OR 7.26, 95% CI 3.37 to 15.66; I² = 0%; 3 RCTs, n = 376; moderate-certainty evidence). This suggests that if the chance of abnormal vaginal bleeding or spotting following endometrial surveillance alone is assumed to be 1.7%, the chance following LNG-IUS with endometrial surveillance would be between 5.6% and 21.5%. By 24 months of follow-up, abnormal vaginal bleeding or spotting occurs less frequently than at 12 months of follow-up, but is still more common in the LNG-IUS group than the control group (Peto OR 2.72, 95% CI 1.04 to 7.10; I² = 0%; 2 RCTs, n = 233; moderate-certainty evidence). This suggests that if the chance of abnormal vaginal bleeding or spotting following endometrial surveillance alone is assumed to be 4.2%, the chance following LNG-IUS with endometrial surveillance would be between 4.4% and 23.9%. By 60 months of follow-up, there were no cases of abnormal vaginal bleeding or spotting in either group. The numbers of events for the following outcomes were low: fibroids (n = 13), breast cancer recurrence (n = 18), and breast cancer-related deaths (n = 16). As a result, there is probably little or no difference in these outcomes between the LNG-IUS treatment group and the control group.  AUTHORS' CONCLUSIONS: The LNG-IUS probably slightly reduces the incidence of benign endometrial polyps and endometrial hyperplasia in women with breast cancer taking tamoxifen. At 12 and 24 months of follow-up, the LNG-IUS probably increases abnormal vaginal bleeding or spotting among women in the treatment group compared to those in the control. Data were lacking on whether the LNG-IUS prevents endometrial cancer in these women. There is no clear evidence from the available RCTs that the LNG-IUS affects the risk of breast cancer recurrence or breast cancer-related deaths. Larger studies are necessary to assess the effects of the LNG-IUS on the incidence of endometrial cancer, and to determine whether the LNG-IUS might have an impact on the risk of secondary breast cancer events.


Assuntos
Neoplasias da Mama/prevenção & controle , Hiperplasia Endometrial/prevenção & controle , Neoplasias do Endométrio/prevenção & controle , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Recidiva Local de Neoplasia/prevenção & controle , Adenocarcinoma/induzido quimicamente , Adenocarcinoma/prevenção & controle , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/química , Neoplasias da Mama/mortalidade , Quimioterapia Adjuvante , Intervalos de Confiança , Anticoncepcionais Femininos/administração & dosagem , Hiperplasia Endometrial/induzido quimicamente , Hiperplasia Endometrial/epidemiologia , Neoplasias do Endométrio/induzido quimicamente , Neoplasias do Endométrio/epidemiologia , Feminino , Humanos , Levanogestrel/efeitos adversos , Recidiva Local de Neoplasia/mortalidade , Pólipos/induzido quimicamente , Pólipos/epidemiologia , Pólipos/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamoxifeno/efeitos adversos , Hemorragia Uterina/induzido quimicamente , Hemorragia Uterina/epidemiologia , Útero/efeitos dos fármacos
3.
Cochrane Database Syst Rev ; 9: CD012658, 2020 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-32909630

RESUMO

BACKGROUND: In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens. OBJECTIVES: To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment. SEARCH METHODS: We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods. MAIN RESULTS: Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG-IUS versus non-intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia The LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence), Adverse effects associated with LNG-IUS There was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG-IUS versus no treatment Regression of endometrial hyperplasia One study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Adulto , Idoso , Viés , Anticoncepcionais Femininos/efeitos adversos , Hiperplasia Endometrial/tratamento farmacológico , Hiperplasia Endometrial/patologia , Hiperplasia Endometrial/cirurgia , Feminino , Humanos , Histerectomia/estatística & dados numéricos , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Náusea/etiologia , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Progestinas/administração & dosagem , Progestinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Fatores de Tempo , Hemorragia Uterina/etiologia , Ganho de Peso , Adulto Jovem
4.
Clin Drug Investig ; 40(8): 737-746, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32564301

RESUMO

BACKGROUND AND OBJECTIVE: Vixotrigine is a voltage- and use-dependent sodium channel blocker in development for neuropathic pain management. This study evaluated the effect of coadministration of vixotrigine (metabolized primarily via uridine diphosphate-glucuronosyltransferases) and an oral contraceptive containing ethinyl estradiol (uridine diphosphate-glucuronosyltransferase inducer) and levonorgestrel on the pharmacokinetics and safety of all three compounds. METHODS: In this phase I, open-label, fixed-sequence, multiple-dose study, 36 healthy women received oral vixotrigine 150 mg three times daily for 6 days and once on day 7. This was followed by a washout period, days 8-11. The oral contraceptive was administered alone on days 12-25 and with vixotrigine 150 mg three times daily on days 26-32. Serial blood samples were collected for pharmacokinetic analysis. Safety was assessed. RESULTS: The geometric least-squares mean ratios (90% confidence intervals) for the area under the concentration-time curve over 8 h and maximum concentration of vixotrigine co-administered with an oral contraceptive vs vixotrigine alone were 0.85 (0.82-0.89) and 0.91 (0.87-0.96), respectively. The geometric least-squares mean ratios (90% confidence interval) for area under the concentration-time curve over 24 h and maximum concentration of ethinyl estradiol with vixotrigine vs ethinyl estradiol alone were 0.94 (0.91-0.97) and 0.89 (0.84-0.94), respectively; the ratios for levonorgestrel with vixotrigine vs levonorgestrel alone were 1.06 (0.98-1.16) and 1.05 (0.98-1.13), respectively. No adverse events occurring with vixotrigine alone were deemed related to the study drug by the investigators. CONCLUSIONS: Coadministration of vixotrigine and an oral contraceptive containing ethinyl estradiol and levonorgestrel had no clinically relevant effect on exposure of all three compounds. TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT03324685 (registered 25 October, 2017).


Assuntos
Anticoncepcionais Orais Combinados/farmacologia , Etinilestradiol/farmacologia , Éteres Fenílicos/farmacologia , Prolina/análogos & derivados , Adolescente , Adulto , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Combinados/farmacocinética , Interações Medicamentosas , Etinilestradiol/efeitos adversos , Feminino , Humanos , Levanogestrel/efeitos adversos , Levanogestrel/farmacologia , Pessoa de Meia-Idade , Éteres Fenílicos/efeitos adversos , Prolina/efeitos adversos , Prolina/farmacologia , Adulto Jovem
5.
Medicine (Baltimore) ; 99(22): e20421, 2020 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-32481439

RESUMO

To evaluate the efficacy and feasibility of levonorgestrel-releasing intrauterine device (LNG-IUD) use longer than 5 years in women with adenomyosis.Data were retrospectively collected from patients who were treated with LNG-IUD longer than 5 years at the Chungnam National University hospital for adenomyosis diagnosed with ultrasonography from January 2006 to November 2013.A total of 131 patients who were diagnosed with adenomyosis had treated with LNG-IUD longer than 5 years. The mean duration of keeping 1 device without replacement was 58.35 ±â€Š15.98 months, and total duration of LNG-IUD treatment was 83.86 ±â€Š23.88 months. A total of 51 patients stopped using LNG-IUD after 5 years and the mean age at the time of LNG-IUD removal was 52.46 ±â€Š6.9. LNG-IUD treatment had a significant effect on both menorrhagia and dysmenorrhea starting from the first month of insertion (P < .01), which persisted until 6 years when the effect started to plateau. The decrease in uterine volume was not consistent during the treatment period. The uterine volume decreased significantly only in the first and second year of LNG-IUD treatment and then from eighth to tenth year of LNG-IUD treatment (P < .05). Adverse events after insertion of LNG-IUD decreased significantly after 5 years.LNG-IUD treatment longer than 5 years is an effective and feasible method for patients diagnosed with adenomyosis.


Assuntos
Adenomiose/tratamento farmacológico , Contraceptivos Hormonais/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Adenomiose/patologia , Adulto , Contraceptivos Hormonais/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Menorragia/tratamento farmacológico , Pessoa de Meia-Idade , Tamanho do Órgão , Manejo da Dor , Estudos Retrospectivos , Fatores de Tempo , Útero/efeitos dos fármacos , Útero/patologia
6.
PLoS Med ; 17(5): e1003110, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32442189

RESUMO

BACKGROUND: Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa. METHODS AND FINDINGS: In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection. CONCLUSIONS: In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT01721798.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Infecções por HIV , Dispositivos Intrauterinos de Cobre/efeitos adversos , Levanogestrel/efeitos adversos , Adolescente , Adulto , Anticoncepcionais Femininos/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/etiologia , Humanos , Levanogestrel/uso terapêutico , Masculino , África do Sul , Resultado do Tratamento , Adulto Jovem
8.
Obstet Gynecol ; 135(6): 1306-1312, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32459422

RESUMO

OBJECTIVE: To evaluate the association of different contraceptive methods on the incidence and severity of acne. METHODS: Using a de-identified commercial claims database, we performed a retrospective cohort study evaluating the incidence of clinical encounters for acne in the first year after initiation of contraception among female patients aged 12-40 years who were new contraceptive users. To evaluate the association of contraception class with acne severity, a subgroup analysis was performed among a cohort of patients with a history of acne examining the incidence of treatment escalation from topical acne medications to an oral tetracycline-class antibiotic in the year after initiation of contraception. RESULTS: Among new contraceptive users with no history of acne (N=336,738), compared with combined oral contraceptives (OCs), the copper intrauterine device (IUD) (hazard ratio [HR] 1.14; 95% CI 1.01-1.29) and levonorgestrel IUDs (HR 1.09; 95% CI 1.03-1.16) were associated with increased risk of clinical encounters with acne. Among those with a history of acne (n=21,178), compared with combined OCs, the copper IUD (HR 1.44; 95% CI 1.00-2.06) and levonorgestrel IUDs (HR 1.34; 95% CI 1.10-1.64) were associated with increased risk of treatment escalation from topical acne medications to an oral tetracycline class antibiotic. CONCLUSION: Combined OCs appear to be associated with a modest (or small) protective effect with respect to incident acne and treatment escalation compared with other contraceptive methods. However, absolute differences between contraceptive methods were small.


Assuntos
Acne Vulgar/induzido quimicamente , Acne Vulgar/epidemiologia , Anticoncepção/classificação , Anticoncepcionais Orais Combinados/efeitos adversos , Acne Vulgar/tratamento farmacológico , Adolescente , Adulto , Criança , Anticoncepcionais Femininos/efeitos adversos , Bases de Dados Factuais , Feminino , Humanos , Incidência , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Estudos Retrospectivos , Estados Unidos/epidemiologia , Adulto Jovem
9.
Clin Drug Investig ; 40(5): 395-420, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32162237

RESUMO

INTRODUCTION: The levonorgestrel oral emergency contraceptive is well tolerated and effective, however its use is still limited, mainly due to safety concerns. OBJECTIVE: This systematic review and meta-analysis aimed to summarize current evidence regarding the adverse events, and their prevalence, reported during the use of oral levonorgestrel emergency contraceptives. METHODS: Four electronic databases and the US FDA Adverse Event Reporting System (FAERS) Public Dashboard were searched. Studies that reported or investigated safety outcomes or adverse reactions during the use of levonorgestrel as an emergency oral contraceptive were included. Data on study design, demographics of levonorgestrel and the control cohort, and reported adverse effects were extracted. RESULTS: A total of 47 articles were included in this systematic review, from which it was shown that most of the adverse reactions were common and not serious. Uncommon adverse reactions identified included anorexia, ectopic pregnancy, exanthema, chloasma, miscarriage, and weight gain. Multiple serious adverse events, including convulsion, ectopic pregnancy, febrile neutropenia, stroke, abdominal hernia, anaphylaxis, cancer, ovarian cyst rupture, serious infections, and suicidal ideation, were reported. In addition, the prevalence of adverse events after a levonorgestrel 0.75 mg two-dose regimen and a levonorgestrel 1.5 mg single-dose regimen were not statistically different (p > 0.05). CONCLUSIONS: The most common adverse effects of levonorgestrel were not serious. This systematic review shows that data regarding the adverse reactions of repeated use of levonorgestrel are scarce. Studies on the multiple uses of levonorgestrel emergency contraception are still required to ensure its safety.


Assuntos
Contraceptivos Hormonais/efeitos adversos , Anticoncepcionais Pós-Coito/efeitos adversos , Levanogestrel/efeitos adversos , Contraceptivos Hormonais/administração & dosagem , Anticoncepcionais Pós-Coito/administração & dosagem , Feminino , Humanos , Levanogestrel/administração & dosagem , Gravidez
10.
Acta Obstet Gynecol Scand ; 99(8): 970-982, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-31990981

RESUMO

INTRODUCTION: Epidemiological studies have shown that some hormonal contraceptive methods are associated with increased breast cancer risk, especially if used over long periods. Our objective was to conduct a systematic review and meta-analysis of the literature on the risk of breast cancer development in women using the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS). MATERIAL AND METHODS: We performed a thorough review of peer-reviewed publications from 10 January 1999, through 31 July 2019, using combinations of search terms for breast cancer risk and LNG-IUS in the Medline, EMBASE, LILACS (Latin American and Caribbean Health Sciences Literature), and Scielo databases. This review was registered in PROSPERO (CRD42017059076). Studies reporting breast cancer risk estimates among healthy users of LNG-IUS were included according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) criteria. Two authors performed data extraction, and a third author resolved disagreements. The quality of evidence was evaluated using the Downs and Black instrument. A funnel plot was generated, and a linear regression test of funnel plot asymmetry was used to assess publication bias. Finally, we performed a random-effects model (owing to high study heterogeneity) meta-analysis of seven suitable studies, stratified by the age distribution of patients (<50 years, ≥50 years, and mixed). RESULTS: We identified 96 studies and manually cross-referenced and excluded duplicate articles. Seventy articles were excluded on the basis of the inclusion and exclusion criteria, resulting in the assessment of 26 full-text articles. Eight articles were considered adequate for inclusion in this systematic review, and seven studies were included in the meta-analysis. Three publications were case-control studies and five were cohort studies. According to the Downs and Black instrument, 5 studies were rated as "good" and 3 studies were deemed "fair". Our meta-analysis results indicated increased breast cancer risk in LNG-IUS users: for all women, odds ratio (OR) = 1.16 (95% CI 1.06-1.28, I2  = 78%, P < .01); for women aged <50 years, OR = 1.12 (95% CI 1.02-1.22, I2  = 66%, P = .02); and for women aged ≥50 years, OR = 1.52 (95% CI 1.34-1.72, I2  = 0%, P = .84). CONCLUSIONS: Current evidence suggests that LNG-IUS users have an increased breast cancer risk regardless of age and indication. The effect of LNG-IUS on breast cancer risk seems to be larger in older users. However, our systematic review detected methodological issues across the available studies, and confounding factors may be responsible for at least a fraction of the risk effects associated with LNG-IUS use. Nevertheless, users of LNG-IUS should be aware of these trends. We believe that caution is needed, and risks should be balanced against proven health benefits (eg effective treatment of heavy menstrual bleeding and avoidance of surgical interventions), when prescribing LNG-IUS for long periods of use, especially in women with other known breast cancer risk factors such as old age, obesity, and familial predisposition.


Assuntos
Neoplasias da Mama/induzido quimicamente , Anticoncepcionais Femininos/efeitos adversos , Dispositivos Intrauterinos Medicados , Levanogestrel/efeitos adversos , Feminino , Humanos , Fatores de Risco
12.
Int J Gynaecol Obstet ; 149(1): 10-15, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31777949

RESUMO

OBJECTIVE: To assess the efficacy of ulipristal acetate (UPA) for reducing abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system (LNG-IUS). METHODS: A randomized, double-blind, placebo-controlled pilot study conducted from September 1, 2016 to September 30, 2018, at the University of Campinas, Brazil. LNG-IUS users reporting prolonged or frequent uterine bleeding for at least 1 year were randomized to receive 5 mg UPA per day for 5 days or placebo at an identical regimen. Bleeding was recorded for 90 days after treatment began and was compared between the groups. RESULTS: Of 94 eligible women, 64 with abnormal bleeding associated with LNG-IUS use declined treatment or device removal after counselling regarding anticipated bleeding patterns. For the 25 study participants, differences were nonsignificant between the UPA and placebo groups for number of days before bleeding stopped and days free of bleeding; however, UPA users displayed a trend for shorter duration before bleeding stopped and longer time free of bleeding. A similar trend for mean number of bleeding days at 30-, 60-, and 90-day follow-up was observed. CONCLUSION: A nonsignificant trend in reduction of abnormal bleeding was observed among LNG-IUS users taking 5 mg UPA per day for 5 days compared with placebo; however, further research is needed. CLINICALTRIALS.GOV: NCT03186586.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Norpregnadienos/administração & dosagem , Hemorragia Uterina/tratamento farmacológico , Adulto , Brasil , Anticoncepcionais Femininos/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Levanogestrel/administração & dosagem , Projetos Piloto , Hemorragia Uterina/induzido quimicamente , Adulto Jovem
13.
Int J Gynaecol Obstet ; 148(3): 381-385, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31778208

RESUMO

OBJECTIVE: To assess the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) on standard cardiovascular risk markers among women with thrombophilia and/or previous venous thromboembolism (VTE). METHODS: A prospective cohort study enrolled women aged 18-45 years with thrombophilia and/or a history of VTE who received the 52-mg LNG-IUS (20 µg/d initial release) at the University of Ribeirão Preto Medical School, Brazil, from January 2006 to December 2015. Before and 12 months after LNG-IUS placement, the following cardiovascular risk markers were assessed: lipid profile, body mass index (BMI), blood glucose, systolic blood pressure, diastolic blood pressure, and waist circumference. The primary outcome was changes in cardiovascular risk markers. A subanalysis of anticoagulant users versus non-users was also conducted. RESULTS: In total, 45 women were enrolled. BMI increased by 2.3% after 12 months of LNG-IUS placement (P < 0.01), but the other risk factors did not change. Cardiovascular risk markers were similar between anticoagulant users and non-users after 12 months of LNG-IUS use. CONCLUSION: Among women with thrombophilia and/or previous VTE, cardiovascular risk markers were not found to change significantly after 12 months of LNG-IUS use. The study adds safety information regarding use of the LNG-IUS for women at risk of thromboembolism.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Trombofilia/complicações , Tromboembolia Venosa/complicações , Adolescente , Adulto , Brasil , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Adulto Jovem
14.
BMJ Sex Reprod Health ; 46(2): 139-146, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31754066

RESUMO

INTRODUCTION: There is unmet need for male contraceptive options, but a recent injectable combination male contraceptive trial was terminated early due to adverse events (AEs). METHODS: We examined the frequency of reported AEs by male research participants compared with AEs reported in prescribing information of approved female hormonal contraceptive methods. Published data from trials of the top five most-used female hormonal contraceptives, supplemented by contemporary contraceptive research, were compared with the frequency of AEs reported in a male injectable hormonal contraceptive trial. RESULTS: We observed similar frequencies of AEs reported by users of male contraceptives compared with those reported by female users. Among quantitatively comparable AEs, compared with men, women reported experiencing higher frequencies of headaches, pelvic pain, and weight gain and similar frequencies of decreased libido. Compared with women, men reported experiencing higher frequencies of acne and mood changes. Men discontinued participation due to AEs at a lower frequency than women. CONCLUSIONS: Female hormonal methods generally have similar frequencies of AEs to those reported in a recent male hormonal contraceptive trial, and male users had lower rates of discontinuation due to AEs. There were fewer serious AEs of the male contraceptive than reported in contemporary female trials which resulted in FDA licensure. This suggests there may be implicit bias in the scientific community regarding the level of acceptable risk for users of male contraceptive methods.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Contracepção Hormonal/normas , Segurança do Paciente/normas , Acne Vulgar/epidemiologia , Acne Vulgar/etiologia , Adulto , Anticoncepcionais Masculinos/normas , Anticoncepcionais Masculinos/uso terapêutico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Cefaleia/epidemiologia , Cefaleia/etiologia , Contracepção Hormonal/métodos , Humanos , Levanogestrel/efeitos adversos , Levanogestrel/uso terapêutico , Libido/efeitos dos fármacos , Masculino , Transtornos do Humor/epidemiologia , Transtornos do Humor/etiologia , Segurança do Paciente/estatística & dados numéricos , Dor Pélvica/epidemiologia , Dor Pélvica/etiologia , Progestinas/efeitos adversos , Progestinas/uso terapêutico , Ganho de Peso/efeitos dos fármacos
15.
J Minim Invasive Gynecol ; 27(3): 774-780, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31201942

RESUMO

STUDY OBJECTIVE: This study aims to evaluate the efficacy of the combination of bipolar radiofrequency impedance-controlled endometrial ablation (NovaSure; Hologic Inc., Bedford, MA) and levonorgestrel intrauterine system (LNG-IUS; Mirena; Schering AG, Berlin, Germany) placement in comparison with NovaSure endometrial ablation alone in patients with abnormal uterine bleeding (AUB). DESIGN: A propensity score matching study. SETTING: Beijing Tiantan Hospital, Capital Medical University, Beijing, China. PATIENTS: A retrospective study was conducted on 246 patients with AUB who underwent NovaSure endometrial ablation with (NovaSure+LNG-IUS group) or without (NovaSure group) LNG-IUS between January 2013 and August 2016. To overcome selection bias, propensity score matching was used to establish a 1:1 match between these 2 groups. Accordingly, 41 patients were included in each group. INTERVENTION: NovaSure endometrial ablation, immediately followed by LNG-IUS insertion in the NovaSure+LNG-IUS group, and NovaSure endometrial ablation alone in the control group. MEASUREMENTS AND MAIN RESULTS: Follow-up assessments performed at postablation months 6, 12, and 24 revealed the following: The rate of amenorrhea (78.05% vs 46.34%, 85.37% vs 53.65%, and 87.80% vs 58.54%, respectively; p <.005) and the rate of dysmenorrhea remission (100% vs 70.59%, 100% vs 64.70%, and 100% vs 64.70% [p <.05, p <.01, and p <.01], respectively) were significantly higher in the NovaSure+LNG-IUS group than in the NovaSure group. The rate of reinterventions was similar for both groups at postablation month 6. However, at postablation months 12 and 24, these rates were significantly lower in the NovaSure+LNG-IUS group than in the NovaSure group (0 vs 14.63% and 2.44% vs 21.95% [p <.05 and p <.01], respectively). CONCLUSION: For women with AUB, the combination of NovaSure endometrial ablation and LNG-IUS is more effective than NovaSure alone in achieving amenorrhea, alleviating dysmenorrhea and reducing reinterventions.


Assuntos
Técnicas de Ablação Endometrial/métodos , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Ablação por Radiofrequência/métodos , Hemorragia Uterina/cirurgia , Adulto , China/epidemiologia , Terapia Combinada , Pesquisa Comparativa da Efetividade , Anticoncepcionais Femininos , Impedância Elétrica/uso terapêutico , Técnicas de Ablação Endometrial/efeitos adversos , Técnicas de Ablação Endometrial/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Dispositivos Intrauterinos Medicados/efeitos adversos , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Pontuação de Propensão , Ablação por Radiofrequência/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Hemorragia Uterina/epidemiologia , Adulto Jovem
16.
Eur J Contracept Reprod Health Care ; 24(6): 449-456, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31696740

RESUMO

Objective: To investigate differences in continuation rates between contraceptive and therapeutic use of the levonorgestrel-releasing intrauterine system 52 mg (LNG-IUS) and factors associated with early removal.Methods: Study design: Retrospective consecutive cohort design.Cohort: Women with the insertion of the LNG-IUS for contraceptive or therapeutic use from 1 January 2006 through 1 January 2009 at the Zuyderland Medical Centre, The Netherlands, with a follow-up of 5 years. The continuation period and reasons of early removal were noted. Univariable and multivariable analysis were performed.Results: Follow-up was possible in 2481 women, 1855 (74.8%) in the contraception group, and 626 (25.2%) in the therapy group. Multivariable Cox proportional hazards models showed, that therapeutic use was associated with an increased risk of early removal of the LNG-IUS (HR 1.23; 95% CI 1.08-1.41), as was having one child (HR 1.20; 95% CI 1.04-1.38), and a decreased risk with advancing age (HR 0.96; 95% CI 0.95-0.97). In both groups, an unacceptable bleeding pattern and adverse events were the main reasons of early removal, resulting in very low continuation rates over the years.Conclusion: Therapeutic use, having one child and a younger age are independent risk factors of early removal of the LNG-IUS, in contrast with previous LNG-IUS use which is associated with a lower risk. In both the contraception group and the therapy group, the main reasons for LNG-IUS discontinuation are continuation with a new LNG-IUS, and no more need for an LNG-IUS (for contraception or therapy). An unacceptable bleeding pattern or adverse events are associated with the lowest continuation rates in both groups.


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Dispositivos Intrauterinos Medicados/efeitos adversos , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Levanogestrel/uso terapêutico , Adulto , Fatores Etários , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Características da Família , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Estudos Longitudinais , Países Baixos , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Hemorragia Uterina/induzido quimicamente
17.
Adv Ther ; 36(12): 3381-3389, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31602573

RESUMO

INTRODUCTION: AG200-15, an investigational transdermal contraceptive delivery system or patch, is designed to be a low-dose, non-daily, combined hormonal contraceptive option for women. In this phase 1 study, the in vivo adhesion of the AG200-15 patch was compared to Xulane®, the only contraceptive patch available in the USA. METHODS: This phase 1, randomized, open-label, single-dose, two-treatment, two-period crossover adhesion study compared the 7-day adhesion of the AG200-15 and Xulane contraceptive patches. Eighty-three women, ages 18 to 35 years old, with body mass index (BMI) ≥ 19 kg/m2 and < 35 kg/m2, and weight ≥ 48 kg and < 90 kg were enrolled. Trained study site personnel used a five-point scale to assess patch adhesion daily. A score of 0 reflected at least 90% adhesion; while a score of 4 represented complete detachment of the patch. The primary objective was to compare the adhesion properties of the two patches; AG200-15 would be considered statistically non-inferior to Xulane if the upper 95% confidence limit (CL) of the mean difference in adhesion scores was below + 0.15. RESULTS: The overall mean (standard deviation) scores for AG200-15 (N = 78) and Xulane (N = 77) were 0.14 (0.28) and 0.39 (0.40), respectively (lower scores on the adhesion scale indicate better adhesion). The study demonstrated a difference in mean adhesion scores of - 0.24, meeting the prespecified non-inferiority criterion by demonstrating a one-sided upper CL of - 0.16. Thus, the in vivo adhesion of AG200-15 was shown to be non-inferior to that of Xulane. Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study. CONCLUSION: The in vivo adhesion of AG200-15 is non-inferior to that of Xulane on the basis of the prespecified criterion of the upper bound of the one-sided 95% CL for the mean adhesion score difference being below + 0.15. Both patches were generally well tolerated. FUNDING: Agile Therapeutics, Inc.


Assuntos
Anticoncepcionais/uso terapêutico , Etinilestradiol/uso terapêutico , Levanogestrel/uso terapêutico , Norgestrel/análogos & derivados , Administração Cutânea , Adolescente , Adulto , Índice de Massa Corporal , Anticoncepcionais/administração & dosagem , Anticoncepcionais/efeitos adversos , Estudos Cross-Over , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Estudos de Equivalência como Asunto , Etinilestradiol/administração & dosagem , Etinilestradiol/efeitos adversos , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Norgestrel/administração & dosagem , Norgestrel/efeitos adversos , Norgestrel/uso terapêutico , Oximas/administração & dosagem , Oximas/efeitos adversos , Oximas/uso terapêutico , Adulto Jovem
19.
Int J Gynaecol Obstet ; 147(3): 326-331, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31489621

RESUMO

OBJECTIVE: To determine whether users of the non-fundal levonorgestrel-releasing intrauterine system (LNG-IUS) present with unfavorable bleeding patterns more frequently than fundal LNG-IUS users. METHODS: A prospective cohort was conducted from June, 2016 to January, 2018 involving women aged 18-45 years who wished to use the LNG-IUS as contraception and had no contraindications, endometrial polyps, submucosal myomas, irregular menstrual cycle, or anticoagulant use. Two study groups comprised women using fundal insertion and non-fundal insertion LNG-IUS. Bleeding was evaluated using a diary and pictogram chart. RESULTS: Of the 92 women who participated in the study, those with non-fundal LNG-IUS insertion sustained bleeding at rates greater than 83% (31) in the first 3 months of use, and 58% (14) at 6 months, versus 51% (22) at 3 months and 33% (19) at 6 months in those with fundal insertion (P=0.002 at 3 months; P=0.037 at 6 months). Blood loss in the non-fundal LNG-IUS group was higher than in the fundal LNG-IUS group according to pictograms drawn by participants. CONCLUSION: Women with non-fundal LNG-IUS placement had a higher frequency of sustained bleeding and blood loss volume according to self-reported charts than those with fundal LNG-IUS placement.


Assuntos
Anticoncepcionais Femininos/farmacologia , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/farmacologia , Distúrbios Menstruais/induzido quimicamente , Adulto , Estudos de Casos e Controles , Anticoncepcionais Femininos/efeitos adversos , Feminino , Humanos , Levanogestrel/efeitos adversos , Estudos Prospectivos , Adulto Jovem
20.
Sex Reprod Healthc ; 21: 75-80, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31395237

RESUMO

OBJECTIVES: Few studies, with contradictory results, evaluate intrauterine contraceptives (IUC) and sexual function specifically. This study compares perception of sexual desire related to IUC use and aspects of sexual function in women who use the Lng-IUS with those using the Cu-IUD. STUDY DESIGN: A secondary analysis regarding IUC use based on a larger cross-sectional survey of contraceptive use in Sweden, conducted in 2013. In total, 153 IUC users (103 Cu-IUD and 50 Lng-IUS users) answered the questionnaire. The only inclusion criterion was intrauterine contraceptive use. MAIN OUTCOME MEASURES: Were self-reported sexual desire changes related to contraceptive method. We also analysed aspects of sexual functioning; sexual desire level, sexual activity, orgasm frequency, satisfaction with sex life and satisfaction of desire level. RESULTS: A negative effect on sexual desire due to contraceptive method was reported by 28% of the Lng-IUS users and by 10.1% of the Cu-IUD users (p < 0.05). Results were more marked after adjusting for age, body mass index, depression, parity, switching behaviour, and partnership (OR 5.0; CI: 1.8-13.8). The adjusted odds of reporting low sexual desire level (never or almost never feeling sexual desire) (OR 3.5; CI: 1.1-11.2) as well as low satisfaction with sex life (OR 2.7; CI: 1.2-6.3) was higher in the Lng-IUS group (adjusted for same confounders as above). CONCLUSIONS: The women in this study using the Lng-IUS more often report negative sexual desire effects of their contraception as well as lower sexual desire level compared with women using the Cu-IUD.


Assuntos
Contraceptivos Hormonais/efeitos adversos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Levanogestrel/efeitos adversos , Libido/efeitos dos fármacos , Sexualidade , Adulto , Estudos Transversais , Feminino , Humanos , Orgasmo , Percepção , Satisfação Pessoal , Inquéritos e Questionários , Adulto Jovem
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