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1.
Cancer Chemother Pharmacol ; 93(5): 439-453, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38270613

RESUMO

PURPOSE: Midostaurin, approved for treating FLT-3-mutated acute myeloid leukemia and advanced systemic mastocytosis, is metabolized by cytochrome P450 (CYP) 3A4 to two major metabolites, and may inhibit and/or induce CYP3A, CYP2B6, and CYP2C8. Two studies investigated the impact of midostaurin on CYP substrate drugs and oral contraceptives in healthy participants. METHODS: Using sentinel dosing for participants' safety, the effects of midostaurin at steady state following 25-day (Study 1) or 24-day (Study 2) dosing with 50 mg twice daily were evaluated on CYP substrates, midazolam (CYP3A4), bupropion (CYP2B6), and pioglitazone (CYP2C8) in Study 1; and monophasic oral contraceptives (containing ethinylestradiol [EES] and levonorgestrel [LVG]) in Study 2. RESULTS: In Study 1, midostaurin resulted in a 10% increase in midazolam peak plasma concentrations (Cmax), and 3-4% decrease in total exposures (AUC). Bupropion showed a 55% decrease in Cmax and 48-49% decrease in AUCs. Pioglitazone showed a 10% decrease in Cmax and 6% decrease in AUC. In Study 2, midostaurin resulted in a 26% increase in Cmax and 7-10% increase in AUC of EES; and a 19% increase in Cmax and 29-42% increase in AUC of LVG. Midostaurin 50 mg twice daily for 28 days ensured that steady-state concentrations of midostaurin and the active metabolites were achieved by the time of CYP substrate drugs or oral contraceptive dosing. No safety concerns were reported. CONCLUSION: Midostaurin neither inhibits nor induces CYP3A4 and CYP2C8, and weakly induces CYP2B6. Midostaurin at steady state has no clinically relevant PK interaction on hormonal contraceptives. All treatments were well tolerated.


Assuntos
Bupropiona , Citocromo P-450 CYP2B6 , Citocromo P-450 CYP2C8 , Citocromo P-450 CYP3A , Interações Medicamentosas , Midazolam , Estaurosporina , Estaurosporina/análogos & derivados , Humanos , Feminino , Citocromo P-450 CYP2B6/metabolismo , Citocromo P-450 CYP2B6/genética , Adulto , Citocromo P-450 CYP3A/metabolismo , Bupropiona/farmacocinética , Bupropiona/administração & dosagem , Estaurosporina/farmacologia , Estaurosporina/farmacocinética , Estaurosporina/administração & dosagem , Citocromo P-450 CYP2C8/metabolismo , Midazolam/farmacocinética , Midazolam/administração & dosagem , Masculino , Adulto Jovem , Anticoncepcionais Orais/administração & dosagem , Anticoncepcionais Orais/farmacologia , Anticoncepcionais Orais/farmacocinética , Pessoa de Meia-Idade , Etinilestradiol/farmacocinética , Etinilestradiol/administração & dosagem , Etinilestradiol/farmacologia , Pioglitazona/farmacologia , Pioglitazona/administração & dosagem , Pioglitazona/farmacocinética , Levanogestrel/farmacocinética , Levanogestrel/administração & dosagem , Levanogestrel/farmacologia , Voluntários Saudáveis , Adolescente , Área Sob a Curva , Combinação de Medicamentos
6.
JAMA ; 329(3): 257-259, 2023 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-36548007

RESUMO

This matched-cohort study uses data from the French National Health Insurance database to assess whether a 19.5-mg levonorgestrel intrauterine system, vs a 52-mg system, is associated with increased use of antidepressant, hypnotic, and anxiolytic medications.


Assuntos
Dispositivos Intrauterinos Medicados , Levanogestrel , Psicotrópicos , França , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Psicotrópicos/uso terapêutico , Dispositivos Intrauterinos Medicados/efeitos adversos , Humanos , Feminino
7.
Am Fam Physician ; 105(1): 33-38, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-35029928

RESUMO

Adenomyosis is a clinical condition where endometrial glands are found in the myometrium of the uterus. One in three patients with adenomyosis is asymptomatic, but the rest may present with heavy menstrual bleeding, pelvic pain, or infertility. Heavy menstrual bleeding is the most common symptom. Adenomyosis is distinct from endometriosis (the presence of endometrial glands outside of the uterus), but the two conditions often occur simultaneously. Risk factors for developing adenomyosis include increasing age, parity, and history of uterine procedures. Most patients are diagnosed from 40 to 50 years of age, but younger patients with infertility are increasingly being diagnosed with adenomyosis as imaging modalities improve. Diagnosis of adenomyosis begins with clinical suspicion and is confirmed with transvaginal ultrasonography and pelvic magnetic resonance imaging. Treatment of adenomyosis typically starts with hormonal menstrual suppression. Levonorgestrel-releasing intrauterine systems have shown some effectiveness. Patients with adenomyosis may ultimately have a hysterectomy if symptoms are not controlled with medical therapy.


Assuntos
Adenomiose/diagnóstico , Adenomiose/tratamento farmacológico , Adenomiose/epidemiologia , Adulto , Contraceptivos Hormonais/administração & dosagem , Endometriose/epidemiologia , Feminino , Humanos , Histerectomia/métodos , Infertilidade/epidemiologia , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Imageamento por Ressonância Magnética/métodos , Menorragia/epidemiologia , Pessoa de Meia-Idade , Dor Pélvica/epidemiologia , Gravidez , Fatores de Risco , Ultrassonografia/métodos
8.
Gynecol Endocrinol ; 38(1): 68-72, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34672861

RESUMO

OBJECTIVE: This study aims to assess sexual function (SF) and quality of life (QoL) among women using copper intrauterine devices (Cu-IUD), levonorgestrel-releasing intrauterine system (LNG-IUS) or etonogestrel(ENG)-releasing subdermal implant. METHODS: This is a cross-sectional study involving 213 women who are sexually active, using Cu-IUD, LNG-IUS or ENG implant for at least one year. SF assessment was carried out through the Female Sexual Function Index (FSFI) and QoL was made through The Short Form Health Research. RESULTS: Frequency of sexual dysfunction score in Cu-IUD users was 33.8%; 47.2% in LNG-IUS users and 47.8% in ENG-implant users, without difference between groups. Desire domain had higher score in Cu-IUD users (Cu-IUD:4.20 ± 1.15 × LNG-IUS:3.76 ± 1.17 × ENG-implant:3.63 ± 1.15; p = .009). Between Cu-IUD and LNG-IUS users there was no difference in FSFI score. Total FSFI score was higher in Cu-IUD group when compared only to ENG-implant (Cu-IUD:27.48 ± 6.14 × Implant:25.07 ± 6.89; p = .029). Regarding the QoL score, difference was found only in general health domain (Cu-IUD:65.22 ± 14.91 × LNG-IUS:62.61 ± 19.04 × Implant:58.33 ± 16.46; p = .034), with lower score for implant group. CONCLUSION: There was no difference in the SF total score between the users of Cu-IUD, LNG-IUS and ENG implant. However, the score of the FSFI desire domain and general health status were higher among users of the Cu-IUD.


Assuntos
Desogestrel/efeitos adversos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Qualidade de Vida , Disfunções Sexuais Fisiológicas/epidemiologia , Adulto , Anticoncepcionais Femininos/administração & dosagem , Estudos Transversais , Desogestrel/administração & dosagem , Feminino , Humanos , Levanogestrel/administração & dosagem
9.
Clin Pharmacol Ther ; 111(2): 509-518, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34674227

RESUMO

Combined oral contraceptive pills are the most commonly used hormonal contraceptives for the prevention of unintended pregnancies in United States. They consist of a progestin (e.g., levonorgestrel (LNG)) and an estrogen component, typically ethinyl estradiol (EE). In addition to adherence issues, drug-drug interactions (DDIs) and obesity (women with body mass index (BMI) ≥ 30 kg/m2 ) are prime suspects for decreased LNG efficacy. Therefore, we developed an integrated physiologically-based pharmacokinetic modeling and model-based meta-analysis approach to determine LNG's efficacy threshold concentrations and to evaluate the impact of DDIs and obesity on the efficacy of LNG-containing hormonal contraceptives (HCs). Based on this approach, co-administration of strong CYP3A4 inducers and LNG-containing HCs (LNG150: LNG 150 µg + EE 30 µg and LNG100: LNG 100 µg + EE 20 µg) resulted in a predicted clinically relevant decrease of LNG plasma exposure (women with BMI < 25 kg/m2 : 50-65%; obese women: 70-75%). Following administration of LNG150 or LNG100 in the presence of a CYP3A4 inducer, there was an increase in mean Pearl Index of 1.2-1.30 and 1.80-2.10, respectively, in women with BMI < 25 kg/m2 (incidence rate ratios (IRRs): 1.7-2.2), whereas it ranged from 1.6-1.80 and 2.40-2.85 in obese women (IRR: 2.2-3.0), respectively. Our results suggest that the use of backup or alternate methods of contraception is not necessarily required for oral LNG + EE formulations except within circumstances of both obesity and strong CYP3A4 inducer concomitance following administration of LNG100.


Assuntos
Contraceptivos Hormonais/administração & dosagem , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Sintéticos/administração & dosagem , Etinilestradiol/administração & dosagem , Levanogestrel/administração & dosagem , Modelos Biológicos , Índice de Massa Corporal , Contraceptivos Hormonais/efeitos adversos , Contraceptivos Hormonais/farmacocinética , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Combinados/farmacocinética , Anticoncepcionais Orais Sintéticos/efeitos adversos , Anticoncepcionais Orais Sintéticos/farmacocinética , Indutores do Citocromo P-450 CYP3A/efeitos adversos , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Interações Medicamentosas , Etinilestradiol/efeitos adversos , Etinilestradiol/farmacocinética , Feminino , Humanos , Levanogestrel/efeitos adversos , Levanogestrel/farmacocinética , Obesidade/fisiopatologia , Gravidez , Gravidez não Planejada , Medição de Risco , Fatores de Risco
10.
Pak J Pharm Sci ; 34(5(Special)): 2079-2083, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34862877

RESUMO

Perimenopausal abnormal uterine bleeding (AUB) is most common in ovulation dysfunction, which seriously compromises patients' health. This study aims to evaluate the efficacy of levonorgestrel intrauterine system (Mirena) plus hysteroscopy respectively in perimenopausal AUB. Sixty perimenopausal AUB patients treated with hysteroscopic electric resection in our hospital between January 2020 and December 2020 were enrolled and randomized to control group given dydrogesterone and study group treated with Mirena, with 30 cases in each group. The treatment efficacy, sex hormone level, hemoglobin (Hb) level, endometrial thickness and menstruation conditions were compared. The total efficacy was higher in the study group than that in the control group (P<0.05). The study group had lower follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels and higher Hb levels compared with those of the control group (all P<0.05). Thinner endometrial thickness, lower pictorial blood loss assessment chart (PBAC) scores and shorter duration of menstruation were observed in the study group (all P<0.05). Both Mirena and dydrogesterone enhance the clinical efficacy of hysteroscopic treatment of perimenopausal AUB patients, with the advantages of Mirena being more promising.


Assuntos
Didrogesterona/administração & dosagem , Histeroscopia , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Perimenopausa , Hemorragia Uterina/terapia , Estudos de Casos e Controles , Terapia Combinada , Didrogesterona/efeitos adversos , Feminino , Humanos , Histeroscopia/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Distribuição Aleatória , Fatores de Tempo , Resultado do Tratamento , Hemorragia Uterina/diagnóstico , Hemorragia Uterina/etiologia
11.
Reprod Biomed Online ; 43(5): 864-870, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34629315

RESUMO

RESEARCH QUESTION: How does use of a levonorgestrel-releasing intrauterine system (LNG-IUS) in infertile women with endometrial hyperplasia without atypia affect endometrial hyperplasia regression and pregnancy rates compared with oral medroxyprogesterone acetate (MPA)? DESIGN: This prospective cohort study included 215 infertile women with an indication for assisted reproductive technology (ART) and a diagnosis of endometrial hyperplasia without atypia. Endometrial hyperplasia was diagnosed by hysteroscopic endometrial biopsy. At the time of first- and second-line treatment, patients were offered therapy with either oral MPA 10 mg daily or LNG-IUS. Follow-up biopsies were scheduled after 90 days' treatment. After endometrial hyperplasia regression, patients were admitted to IVF/intracytoplasmic sperm injection (ICSI) cycles. RESULTS: Baseline characteristics and confounders including age at diagnosis, body mass index and duration of infertility did not differ between LNG-IUS users and control participants and were accounted for using propensity score weighting. Endometrial hyperplasia regression rate at first follow-up was higher in the LNG-IUS group than the oral progestins group (28/28, 100% and 110/187, 58.8%; P < 0.001), while that after second-line treatment was comparable between the two groups (89/91, 97.8% and 122/124, 98.4%; P = 0.22). Clinical pregnancy rate, miscarriage rate and cumulative live birth rate following ART in patients ever receiving LNG-IUS were similar to those of patients receiving only MPA (34% versus 39.5%, 22.6% versus 34.7% and 26.4% versus 25.8%). CONCLUSION: Endometrial hyperplasia regression is greater in women receiving LNG-IUS compared with oral MPA, while live birth rates following ART are comparable between the two groups. The use of LNG-IUS does not jeopardize the chances of pregnancy in women seeking fertility treatment.


Assuntos
Hiperplasia Endometrial/tratamento farmacológico , Infertilidade Feminina/etiologia , Infertilidade Feminina/terapia , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Acetato de Medroxiprogesterona/administração & dosagem , Aborto Espontâneo/epidemiologia , Adulto , Estudos de Coortes , Hiperplasia Endometrial/complicações , Hiperplasia Endometrial/patologia , Feminino , Humanos , Nascido Vivo , Gravidez , Taxa de Gravidez , Estudos Prospectivos , Técnicas de Reprodução Assistida , Resultado do Tratamento
12.
Sci Rep ; 11(1): 20141, 2021 10 11.
Artigo em Inglês | MEDLINE | ID: mdl-34635768

RESUMO

The aim of this study was to investigate the effect of a one-rod levonorgestrel implant on the blood chemistry profile, including random blood glucose (RBG), haemoglobin (Hb), alanine transferase (ALT), aspartate transferase (AST), and the lipid profile, including total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. This prospective cohort study was conducted at Raden Saleh Clinic, Jakarta, from 2010 to 2012. The implants were inserted subdermally in 30 patients. The subjects were evaluated every 6 month up to 2 years. Bivariate analysis using t-test or Wilcoxon signed rank test was performed for all variables. p < 0.05 was considered a significant value. The Hb, RBG, AST, and lipid profile levels were significantly different before and 6 months after one-rod implant insertion (p < 0.05). However, for 24 months, all of the parameters were still within normal limits and did not differ clinically. One-rod levonorgestrel implant insertion has a minimal effect on all blood chemistry profiles.


Assuntos
Análise Química do Sangue/métodos , Anticoncepcionais Femininos/administração & dosagem , Levanogestrel/administração & dosagem , Lipídeos/sangue , Adulto , Colesterol/sangue , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Ensaios Clínicos Fase II como Assunto , Anticoncepcionais Femininos/farmacologia , Implantes de Medicamento , Feminino , Humanos , Levanogestrel/farmacologia , Estudos Prospectivos , Triglicerídeos/sangue , Adulto Jovem
13.
PLoS One ; 16(9): e0257769, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34587200

RESUMO

BACKGROUND: Despite the positive characteristics of the levonorgestrel-releasing intrauterine device (IUD)-a long-acting, highly effective contraceptive with important non-contraceptive attributes-the method has not been widely available in low- and middle-income countries. This study of hormonal IUD, copper IUD, implant and injectable users in Nigeria compares their characteristics, reasons for method choice, and experiences obtaining their method. METHODS: We conducted a phone survey with 888 women who received a hormonal IUD, copper IUD, contraceptive implant or injectable from 40 social franchise clinics across 18 states in Nigeria. We analyzed survey data descriptively by method and assessed factors associated with hormonal IUD use through multivariate logistic regression models. Follow-up in-depth interviews conducted with 32 women were analyzed thematically. RESULTS: There were few differences by method used in the socio-demographic profiles and contraceptive history of participants. Among users choosing a long-acting, reversible method, the top reasons for method choice included perceptions that the method was "right for my body," long duration, recommended by provider, recommended by friends/family, few or manageable side effects, and high effectiveness. Among hormonal IUD users, 17% mentioned reduced bleeding (inclusive of lighter, shorter, or no period), and 16% mentioned treatment of heavy or painful periods. Qualitative data supported these findings. Among survey respondents, between 25% and 33% said they would have chosen no method if the method they received had not been available. Both quantitative and qualitative data indicated that partner support can affect contraceptive use, with in-depth interviews revealing that women typically needed partner permission to use contraception, but men were less influential in method choice. CONCLUSIONS: Expanding access to the hormonal IUD as part of a full method mix provides an opportunity to expand contraceptive choice for women in Nigeria. Findings are timely as the government is poised to introduce the method on a wider scale.


Assuntos
Anticoncepção/instrumentação , Anticoncepcionais Femininos/administração & dosagem , Implantes de Medicamento/administração & dosagem , Levanogestrel/administração & dosagem , Adulto , Anticoncepção/psicologia , Feminino , Humanos , Injeções , Dispositivos Intrauterinos de Cobre/estatística & dados numéricos , Pessoa de Meia-Idade , Nigéria , Estudos Prospectivos , Inquéritos e Questionários , Adulto Jovem
14.
Rev. Méd. Clín. Condes ; 32(4): 502-510, jul - ago. 2021. ilus, tab, graf
Artigo em Espanhol | LILACS | ID: biblio-1525859

RESUMO

Los dispositivos intrauterinos hormonales de levonorgestrel son métodos anticonceptivos seguros y eficaces. Al igual que los medicamentos convencionales, una vez expirada la patente, las autoridades regulatorias de salud pueden aprobar el registro de productos similares. El objetivo de ello es disminuir los costos, considerando el elevado precio del producto original. Este tipo de productos están regulados y se aplican requisitos generales similares a los medicamentos tradicionales para demostración de seguridad y eficacia. Las propiedades mecánicas únicas del producto de referencia plantean un gran desafío a los productos similares. El presente artículo analiza de manera comparativa las características de los diversos sistemas intrauterinos hormonales de levonorgestrel, disponibles en el mercado. La autoridad sanitaria y los diversos centros clínicos deben considerar que en este tipo de productos no hay, hasta la fecha en el mundo, genéricos intercambiables y que por lo tanto, se debe decidir la intercambiabilidad de éstos sobre la base de estudios de bioequivalencia in vivo, luego de la demostración de equivalencia farmacéutica in vitro, tal y como sugiere la FDA, o en su defecto deberían ser registrados como productos nuevos, con estudios clínicos apropiados que demuestren seguridad y eficacia.


Levonorgestrel hormonal intrauterine systems are safe and effective contraceptive methods. Like conventional drugs, once the patent expires, health regulatory authorities can approve the registration of similar products. The objective of this is to reduce costs, considering the high price of the original product. These types of products are regulated as drugs and similar general requirements apply to traditional drugs for demonstration of safety and efficacy. The unique mechanical properties of the reference product pose a great challenge to similar products. This article comparatively analyzes the characteristics of the various levonorgestrel hormonal intrauterine systems available on the market. Therefore, the health authority and clinical centers must consider that up to date, there are no interchangeable generics in this type of products worldwide. Thus, their interchangeability must be decided on the basis of in vivo bioequivalence studies after the demonstration of in vitro pharmaceutical equivalence, as suggested by the FDA. Without that, they should be registered as new products, with appropriate clinical studies that demonstrate safety and efficacy.


Assuntos
Humanos , Feminino , Levanogestrel/administração & dosagem , Dispositivos Intrauterinos Medicados , Segurança , Eficácia
15.
BJOG ; 128(12): 2003-2011, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34245652

RESUMO

OBJECTIVE: To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. METHODS: Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point. CONCLUSIONS: A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept. TWEETABLE ABSTRACT: Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.


Assuntos
Técnicas de Ablação Endometrial/economia , Dispositivos Intrauterinos Medicados/economia , Levanogestrel/economia , Menorragia/economia , Menorragia/terapia , Adulto , Análise Custo-Benefício , Feminino , Humanos , Levanogestrel/administração & dosagem , Países Baixos , Resultado do Tratamento
16.
Fertil Steril ; 116(4): 1191-1193, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34238576

RESUMO

OBJECTIVE: To introduce an effective approach using the hysteroscopic cold-knife surgery system (HCSS) for suture fixation of the levonorgestrel-releasing intrauterine device (LNG-IUD) in patients with adenomyosis. DESIGN: Video description of the surgical procedures to demonstrate the detailed technique. The study was reviewed and approved by the institutional review board of Hangzhou Women's Hospital. SETTING: Maternity hospital. PATIENT(S): A 39-year-old woman diagnosed with adenomyosis had endured 7 years of severe dysmenorrhea and 4 years of heavy menstrual bleeding. She had a past medical history that was significant for expulsion of an LNG-IUD. Transvaginal ultrasonography revealed that her uterus was enlarged by adenomyosis. She insisted on preserving fertility potential. INTERVENTION(S): We proceeded with the HCSS and the uterine cavity was found enlarged significantly. In consideration of the patient's strong desire for maintaining fertility options, the fixation of the LNG-IUD on the intrauterine posterior wall with an Ethibond suture was performed successfully through an endoscopic needle driver and a knot-pushing device. Proficient endoscopic suturing is the key to the technique. Informed consent was obtained from the patient. MAIN OUTCOME MEASURE(S): Feasibility and value of using the HCSS to fix an LNG-IUD for treatment of adenomyosis. RESULT(S): The LNG-IUD was fixed successfully by the HCSS with an Ethibond suture on the posterior wall of the uterus within 30 minutes, and the intraoperative blood loss was 2 mL. The patient was discharged 24 hours postoperatively without any adverse perioperative complications. At the one-year follow-up, the patient reported obvious relief of her dysmenorrhea and menorrhagia and no more experience with expulsion. Ultrasound demonstrated normal position of the IUD at 1, 3, 6, and 12 months postoperatively. CONCLUSION(S): Hysteroscopy presents a clear visual field to locate and fix the IUD. In patients with adenomyosis suffering from dysmenorrhea or excessive menstrual blood loss, suture fixation of the LNG-IUD using the HCSS can be a minimally invasive and effective alternative for treating adenomyosis, especially in patients who have previously expelled an LNG-IUD, preventing the risk of expulsion.


Assuntos
Adenomiose/terapia , Contraceptivos Hormonais/administração & dosagem , Criocirurgia , Histeroscopia , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Técnicas de Sutura , Adenomiose/diagnóstico por imagem , Adulto , Feminino , Humanos , Resultado do Tratamento
17.
Eur J Contracept Reprod Health Care ; 26(5): 399-403, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34096433

RESUMO

PURPOSE: This study aimed to assess the pain scores at the insertion of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) among nulligravidas, parous women with previous vaginal delivery and parous women with elective caesarean-delivery without any previous labour or cervix dilation. MATERIALS AND METHODS: The present research is a prospective, single-cohort study that included 413 women aged 15-49 years who opted for LNG-IUS placement for contraception or treatment of heavy menstrual bleeding. Women who participated in the present study were not submitted to any pharmacological pain-relieving intervention to perform the procedure. Pain at insertion was evaluated by using a Visual Analogue Scale (VAS). Pain was classified as absent (0), mild (1-3), moderate (4-6), or severe (7-10). The women were divided as: (1) nulligravidas, (2) parous women with a previous vaginal delivery, or (3) parous women with elective caesarean-delivery without any previous labour or cervix dilation. RESULTS: Nulligravidas women presented a higher mean pain score, when compared to women with elective caesarean-delivery and women with previous vaginal delivery (6.6 ± 2.0 vs 5.5 ± 2.1 and 3.9 ± 2.4, respectively; p < 0.001). Nulligravidas and women with elective caesarean-delivery were more likely to have pain classified as moderate or severe (in relation to absent or mild) than women with previous vaginal delivery (p < 0.001). Multiple Linear Regression Analysis demonstrated that 29.5% of all variability of the pain score was explained by two predictor/independent variables: nulligravidas or women with elective caesarean and difficulty at IUD insertion. CONCLUSIONS: Women with previous vaginal delivery had lower pain scores at LNG-IUS insertion when compared to nulligravidas and women with elective caesarean-delivery without any previous labour.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Sistemas de Liberação de Medicamentos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/administração & dosagem , Dor/tratamento farmacológico , Administração Intravaginal , Adolescente , Adulto , Estudos de Coortes , Anticoncepcionais Femininos/administração & dosagem , Feminino , Humanos , Pessoa de Meia-Idade , Dor/etiologia , Manejo da Dor , Medição da Dor , Paridade , Gravidez , Estudos Prospectivos , Adulto Jovem
18.
Eur J Contracept Reprod Health Care ; 26(5): 390-398, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34047657

RESUMO

PURPOSE: Up to 30% of women of reproductive age experience HMB, which has a substantial impact on their quality of life. A clinical care pathway for women with HMB is an unmet need, but its development requires better understanding of the factors that characterise current diagnosis and management of the condition. MATERIALS AND METHODS: This observational, survey-based study assessed the burden, personal experiences, and path through clinical management of women with HMB in Canada, the USA, Brazil, France and Russia using a detailed, semi-structured online questionnaire. After excluding those reporting relevant organic pathology, responses to the questionnaire from 200 women per country were analysed. RESULTS: Around 75% of women with HMB had actively sought information about heavy periods, mostly through internet research. The mean time from first symptoms until seeking help was 2.9 (Standard deviation, 3.1) years. However, 40% of women had not seen a health care professional about the condition. Furthermore, 54% had never been diagnosed or treated. Only 20% had been diagnosed and received appropriate treatment. Treatment was successful in 69% of those patients currently receiving treatment. Oral contraceptives were the treatment most commonly prescribed for HMB, although the highly effective levonorgestrel-intrauterine system was used by only a small proportion of women. CONCLUSIONS: This study provides insight into the typical journey of a woman with HMB which may help patients and health care professionals improve the path to diagnosis and treatment, although further research with long-term outcomes is needed.


Assuntos
Contracepção Hormonal/métodos , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Qualidade de Vida/psicologia , Adolescente , Adulto , Anticoncepcionais Orais/administração & dosagem , Diagnóstico Tardio , Feminino , Acesso aos Serviços de Saúde , Inquéritos Epidemiológicos , Humanos , Levanogestrel/administração & dosagem , Menorragia/psicologia , Pessoa de Meia-Idade , Inquéritos e Questionários , Resultado do Tratamento
19.
Eur J Contracept Reprod Health Care ; 26(4): 303-311, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33960248

RESUMO

BACKGROUND: To estimate the cost-effectiveness (CE) of etonogestrel implants compared to other long-term and short-term reversible contraceptive methods available in France. RESEARCH DESIGN AND METHODS: A 6-year Markov model compared effectiveness between the implant and six other contraceptive methods in sexually active, not-pregnancy-seeking French females of reproductive age. Contraception efficacy, switch rates and outcomes were based on French current medical practice. Incremental CE ratios (ICERs) were calculated as incremental cost per unintended pregnancy (UP) avoided. Efficiency frontier was plotted to identify cost-effective methods. Uncertainty was explored through sensitivity analyses. RESULTS: The implant was on the efficiency frontier along with combined oral contraceptive pill (COC) and copper IUD. Implant avoids between 0.75% and 3.53% additional UP per person-year compared to copper IUD and second generation COC, respectively, with an ICER of €2,221 per UP avoided compared to copper IUD. For the 240,000 French women currently using the implant, up to 8,475 UPs and up to 1,992 abortions may be prevented annually. CONCLUSION: With more unintended pregnancies avoided and comparable costs to copper IUD, the implant is a cost-effective option among long-term and short-term reversible contraceptive methods.


Assuntos
Anticoncepcionais Femininos , Desogestrel/economia , Levanogestrel/economia , Contracepção Reversível de Longo Prazo/economia , Adolescente , Adulto , Anticoncepção , Anticoncepcionais Orais/economia , Análise Custo-Benefício , Desogestrel/administração & dosagem , Vias de Administração de Medicamentos , Feminino , França , Humanos , Levanogestrel/administração & dosagem , Contracepção Reversível de Longo Prazo/métodos , Pessoa de Meia-Idade , Modelos Econômicos , Gravidez , Adulto Jovem
20.
Rev Bras Ginecol Obstet ; 43(4): 291-296, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33979890

RESUMO

OBJECTIVE: To evaluate whether continuation rates with the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) up to 5 years after placement differed between women using the method exclusively for contraception and those using the device for medical reasons alone. METHODS: A retrospective cohort study was conducted in a family planning clinic with 5,034 LNG-IUS users: 4,287 using the method exclusively for contraception and 747 for medical reasons alone. The continuation rate at 1 to 5 years of use was calculated by life table analysis. RESULTS: Initially, the continuation rate was significantly higher in the contraception group: 85.8 versus 83.4 and 77.4 versus 76.0 per 100 women-years in the 1st and 2nd years of use, respectively. There were more discontinuations due to bleeding/spotting in the medical reasons group in the first two years. The discontinuation rate according to reason for use was not significantly different from the third to the fifth year of use. No women discontinued due to amenorrhea in either group. CONCLUSION: The continuation rate was significantly higher in the contraception group in the first two years of use. Amenorrhea was not a reason for discontinuation in either group, suggesting that counselling in this respect was adequate. Nevertheless, counselling could perhaps have been better with regards to the expected long period of bleeding and spotting in the first two years after placement.


OBJETIVO: Avaliar a taxa de continuação até 5 anos de uso do sistema intrauterino liberador de 52-mg levonorgestrel por dia (SIU LNG) -IUS) é diferente entre mulheres que o usam exclusivamente como anticoncepcional que entre as que usam exclusivamente por razões médicas. MéTODOS: Estudo retrospectivo realizado em uma clínica de Planejamento Familiar 5.034 usuárias de SIU LNG, 4.287 que optaram pelo método apenas como anticoncepcional e 747 que o usavam somente por razoes médicas. A taxa de continuação de um até cinco ano foi calculada por meio de análise de tabela de vida RESULTADOS: No início a taxa de continuação foi significativamente maior no grupo da anticoncepção: 85,8 versus 83,4 e 77,4 versus 76,0 por 100 anos-mulher no 1° e 2° ano de uso, respectivamente. Houve mais descontinuações por sangrado-manchado no grupo de razões médicas nos dos primeiros anos. A taxa de continuação não foi significativamente diferente desde o terceiro até o quinto ano de uso. Nenhuma mulher de ambos os grupos descontinuou por amenorreia. CONCLUSãO: A taxa de continuação foi significativamente maior no grupo de anticoncepção durante os dos primeiros anos de uso. Amenorreia não foi motivo de descontinuação em ambos os grupos, sugerindo que a orientação a esse respeito foi adequada. Entretanto, a orientação referente ao longo período de sangramentos irregulares nos dois primeiros anos após a inserção, precisaria ser melhorado.


Assuntos
Contraceptivos Hormonais/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Adulto , Brasil , Contraceptivos Hormonais/efeitos adversos , Aconselhamento , Escolaridade , Feminino , Seguimentos , Humanos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Estado Civil , Distúrbios Menstruais , Paridade , Educação de Pacientes como Assunto , Análise de Regressão , Estudos Retrospectivos , Adulto Jovem
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