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1.
Pak J Pharm Sci ; 32(1(Supplementary)): 315-322, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30829209

RESUMO

Vulvo-Vaginal Candidiasis is common gynecological disorder. Clinical trials are designed to evaluate the effect of medical intervention with allopathic and herbal medicine to treat vulvo-vaginal candidiasis. The toxicity index and the safety profile of test drug were assessed on animals' model. Toxicity study of polyherbal formulation was done in order to consider it safe before use. In acute toxicity study, a single dose of 2000 mg/kg was given to Swiss Albino mice and in sub-acute toxicity study three different doses were given to Wistar rats. Randomized Controlled Clinical Trials was conducted. Inclusion and exclusion criteria and informed consent from the patients were to be monitored. In acute toxicity study no morbidity and mortality noticed on single administration of dose 2000mg/kg/day. In sub -acute toxicity study no significant changes were observed in consumption of food and water, body weight, hematological parameters, Liver function test, renal function parameters and lipid profile. The statistical analysis showed C. albican was eradicated in 59 participants (78%) out of 75 participants by the use of Candicure (Test drug) and in 56 participants (74%) out of 75 participants by the use of Fluconazole therapy (Control drug). Chi-square test was applied and p-value was calculated 0.3101 which is greater than 0.05 showed that Candicure therapy and Fluconazole therapy is equally significant in eradication of C. albican. The acute and sub-acute toxicity study of polyherbal formulation on experimental animals is safe at a dose of 2000mg/kg/day. The clinical findings of randomized controlled trial revealed that the effect was almost comparable to control drug in eradicating the micro-organism.


Assuntos
Antifúngicos/farmacologia , Candidíase/tratamento farmacológico , Preparações de Plantas/farmacologia , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/tratamento farmacológico , Animais , Feminino , Masculino , Camundongos , Ratos Wistar , Testes de Toxicidade Aguda , Testes de Toxicidade Subcrônica , Resultado do Tratamento , Doenças Vaginais/etiologia , Doenças da Vulva/etiologia
2.
Medicine (Baltimore) ; 98(7): e14572, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30762806

RESUMO

BACKGROUND: Chlamydia trachomatis can lead to a persistent infection in the lower gastrointestinal tract, suggesting a potential role of autoinoculation of cervical chlamydial infection from the rectal site, contributing to repeat infections. Moreover, around 75% of women with urogenital C. trachomatis have concurrent anorectal infection. Current treatment guidelines for urogenital C. trachomatis infection recommend either a single 1 g dose of azithromycin or doxycycline 100 mg twice daily for 7 days. Doxycycline appears to be more effective in treating anorectal infections as suggested in a population of men who have sex with men, but no randomized controlled trial (RCT) had directly compared azithromycin with doxycycline for the treatment of rectal infections. We propose an open-label RCT to compare the microbial cure obtained with a single 1 g dose of azithromycin versus 100 mg of doxycycline twice daily for 7 days, for the treatment of anorectal C. trachomatis infection concurrent to urogenital infection in women. METHODS AND STUDY DESIGN: A total of 460 women with C. trachomatis urogenital infection will be enrolled in the study. Women will be asked to provide self-collected anorectal swabs and will be randomized to receive either a 1 g single dose of azithromycin or doxycycline 100 mg twice daily for 7 days. Clinical and biological data will be collected and patients will complete questionnaires about their sexual behavior. The primary outcome is the microbial cure rate, defined as a C. trachomatis negative nucleic acid amplification test (NAAT) result in the anorectal specimens 6 weeks after treatment initiation among women with a C. trachomatis positive urogenital and anorectal NAAT result at the baseline. The secondary outcome is autoinoculation from the rectum to the vagina, which will be evaluated based on the number of women with the same C. trachomatis genotype profile that will be identified in an anorectal-positive specimen obtained 6 weeks after treatment initiation and in a vaginal-positive specimen obtained four months after treatment. DISCUSSION: The results of this trial will establish which treatment is more efficacious against anorectal infection and could affect recommendations for the treatment of urogenital C. trachomatis infection, taking into account concurrent anorectal infection. TRIAL REGISTRATION NUMBERS: EudraCT number: 2017-002595-15. CLINICALTRIALS. GOV IDENTIFIER: NCT03532464. Date of registration: May 31, 2018. WORLD HEALTH ORGANISATION INTERNATIONAL CLINICAL TRIALS REGISTRY: NTC03532464. Secondary ID: CHUBX 2016/26. Date of registration: May 09, 2018.


Assuntos
Antibacterianos/uso terapêutico , Azitromicina/uso terapêutico , Infecções por Chlamydia/tratamento farmacológico , Doxiciclina/uso terapêutico , Doenças Retais/tratamento farmacológico , Doenças Vaginais/tratamento farmacológico , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Azitromicina/administração & dosagem , Azitromicina/efeitos adversos , Chlamydia trachomatis , Doxiciclina/administração & dosagem , Doxiciclina/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Doenças Retais/complicações , Doenças Retais/microbiologia , Projetos de Pesquisa , Doenças Vaginais/complicações , Doenças Vaginais/microbiologia
3.
Support Care Cancer ; 27(4): 1325-1334, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30729333

RESUMO

PURPOSE: Vaginal atrophy is one of the most common side effects of using tamoxifen in women with breast cancer. Hormone therapy for vaginal atrophy is prohibited in these women. The present study was conducted to investigate the effect of vitamin D and E vaginal suppositories on vaginal atrophy in women with breast cancer receiving tamoxifen. METHODS: Women under breast cancer management receiving tamoxifen and showing symptoms of vaginal atrophy were randomized triple-blind to an 8-week trial on vaginal suppository vitamin E or vitamin D or placebo administered every night before bedtime. The genitourinary atrophy self-assessment tool was administered, and pH was measured in all three groups before the intervention and at the end of weeks 2, 4, and 8 of the intervention. The Vaginal Maturation Index (VMI) was also measured before the intervention and at the end of the eighth week. Data were analyzed with paired t tests, repeated measures analysis of variance, and chi-square test. RESULTS: Thirty-two patients were randomized in each group. The results obtained showed an increase in the VMI by the end of the eighth week of the intervention in the groups receiving the vitamin D and E vaginal suppositories compared with the placebo group (P < 0.001). The vaginal pH also reduced in both groups compared with that in the placebo group (P < 0.001). The symptoms of self-reported genitourinary atrophy also improved in the two intervention groups compared with those in the placebo group by the end of the eighth week (P < 0.001). CONCLUSION: These data support that vitamin D and E vaginal suppositories were beneficial in improving vaginal atrophy in women with breast cancer receiving tamoxifen. Given the prohibition on hormone therapy in these women, the suppositories can be used as an alternative therapy to improve these symptoms.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Tamoxifeno/efeitos adversos , Vagina/efeitos dos fármacos , Doenças Vaginais/induzido quimicamente , Doenças Vaginais/tratamento farmacológico , Vitamina D/administração & dosagem , Vitamina E/administração & dosagem , Adulto , Atrofia/induzido quimicamente , Atrofia/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Irã (Geográfico) , Pessoa de Meia-Idade , Pós-Menopausa , Supositórios , Tamoxifeno/administração & dosagem , Vagina/patologia , Vitamina D/farmacologia , Vitamina E/farmacologia
4.
PLoS One ; 14(1): e0210967, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30677065

RESUMO

This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer treatment and experiencing vulvovaginal dryness symptoms. Overall, 128 patients from 22 study centers participated. The cream was applied to the vagina and vulva for 28 days. For the efficacy analysis, changes in subjective symptoms (feeling of dryness, itching, burning, pain independent of sexual intercourse, dyspareunia, urinary incontinence) were evaluated. Additionally, the following objective diagnostic findings were assessed by a physician: thinning of vaginal epithelium, redness, petechiae, and discharge. Safety and tolerability were assessed by evaluating type and frequency of adverse events, including adverse medical device-related effects. The frequency and intensity of all subjective symptoms significantly improved from baseline at 28 days (p<0.0001). Additionally, 21.4% of patients were completely free of symptoms (p<0.0001) and urinary incontinence was improved or eliminated in 30.8% of women. The overall sum score for all four objective findings was significantly improved from baseline at 28 days (p<0.0001). The frequency of petechial bleedings was significantly reduced (p<0.0001). Further, significant decreases in the severity of vaginal epithelium thinning, redness and petechiae were observed (p<0.0001). More than 88% of patients and investigators assessed the efficacy and tolerability as being good or very good. No serious adverse events were documented. This study demonstrates that the investigated cream is an effective and safe non-hormonal, topical option in the treatment of vulvovaginal dryness symptoms in patients undergoing breast cancer treatment for. However, the study duration and follow-up time of 4 weeks as well as the non-randomized trial design are limitations of the study.


Assuntos
Cremes, Espumas e Géis Vaginais/uso terapêutico , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Administração Tópica , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/efeitos adversos , Atrofia , Emulsões/administração & dosagem , Feminino , Humanos , Lubrificantes/administração & dosagem , Menopausa Precoce/efeitos dos fármacos , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Vagina/patologia , Cremes, Espumas e Géis Vaginais/administração & dosagem , Doenças Vaginais/patologia , Doenças Vaginais/fisiopatologia , Vulva/patologia
5.
Eur J Obstet Gynecol Reprod Biol ; 234: 92-95, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30677618

RESUMO

OBJECTIVE: Evaluate the efficacy and safety of a non-hormonal intravaginal moisturizer on reducing the symptoms arising from vaginal dryness and sexual dysfunction. STUDY DESIGN: A total of 37 postmenopausal women used a non-hormonal intravaginal Moisturizer (polycarbophil, butyl ester of a copolymer of methyl vinyl ether/ copolymer PVM/MA, 50% sodium lactate solution, and Carbopol) twice a week for 12 weeks. The vaginal moisture levels, volume of fluid, elasticity, and epithelium integrity were assessed using the Vaginal Health Index. Sexual function was measured using the Female Sexual Function Index questionnaire. All women were evaluated before starting treatment and at the 4th, 8th and 12th weeks of the study. At the end of the study, the patients analysed the treatment regarding to their satisfaction with the product, and its application system, their sense of well-being after using it as well as their perception bout the discharge of the moisturizer (if it run or was held by the vaginal mucosa). RESULTS: There was a significant improvement in the vaginal moisture, fluid volume, elasticity and epithelial integrity (p < 0.001). Sexual function improved in the total score and in all six domains (p < 0.001). More than 50% of all patients reported being very satisfied with the treatment and product application. The sense of well-being was considered very good by 51.4% of the participants and most (91.9%) indicated that the product did not leak and did not stick to the vaginal mucosa. No severe adverse events were reported. CONCLUSION: Our study suggests that treatment with the non-hormonal intravaginal moisturizer is a safe and efficient therapeutic option for the improvement of vaginal dryness with encouraging benefits for the sexual function of postmenopausal women.


Assuntos
Lubrificantes/uso terapêutico , Vagina/efeitos dos fármacos , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Idoso , Dispareunia/tratamento farmacológico , Dispareunia/etiologia , Feminino , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Pós-Menopausa/fisiologia , Estudos Prospectivos , Vagina/patologia , Cremes, Espumas e Géis Vaginais , Doenças Vaginais/complicações
6.
Menopause ; 26(6): 611-621, 2019 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-30694917

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). METHODS: This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies. RESULTS: Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. CONCLUSIONS: Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.


Assuntos
Pós-Menopausa/fisiologia , Moduladores Seletivos de Receptor Estrogênico/efeitos adversos , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Índice de Gravidade de Doença , Tamoxifeno/análogos & derivados , Vagina/patologia , Doenças Vaginais/tratamento farmacológico , Vulva/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Atrofia/tratamento farmacológico , Método Duplo-Cego , Dispareunia/tratamento farmacológico , Feminino , Fogachos/etiologia , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Moduladores Seletivos de Receptor Estrogênico/administração & dosagem , Tamoxifeno/administração & dosagem , Tamoxifeno/efeitos adversos , Tamoxifeno/uso terapêutico , Resultado do Tratamento
7.
Australas J Dermatol ; 60(1): 7-11, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29961956

RESUMO

Vulvo-vaginal lichen planus is a condition which imposes a significant burden of symptoms and sequale. There is a paucity of knowledge and evidenced-based management with significant diagnostic delay prior to appropriate treatment being common. There remains great variability in clinician practice in the context of limited knowledge. This clinical review presents current evidence on the clinicopathological features, practical assessment and management options. Learning points include characterization of this chronic, burdensome clinical entity that has no standardized diagnostic or management protocols. We provide practical clinical conclusions based on current knowledge and identify areas for future research to improve patient outcomes.


Assuntos
Líquen Plano/diagnóstico , Líquen Plano/tratamento farmacológico , Doenças Vaginais/diagnóstico , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/diagnóstico , Doenças da Vulva/tratamento farmacológico , Corticosteroides/uso terapêutico , Feminino , Humanos , Imunossupressores/uso terapêutico , Líquen Plano/terapia , Fotoquimioterapia , Doenças Vaginais/terapia , Doenças da Vulva/terapia
8.
Surg Technol Int ; 34: 269-273, 2019 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-30388724

RESUMO

Vulvo-vaginal atrophy as a main symptom of the Genito Urinary Syndrome of Menopause (GSM) is a consequence of aging, particularly after menopause as a result of follicular ovarian follicle depletion and consequently low estrogen levels. Anatomical structures derived from the urogenital sinus, such as the distal urethra trigone and vestibule, are the most affected areas because of the high concentrations of alfa- and beta-estrogen receptors. The most common symptoms associated with vulvo-vaginal atrophy are dyspareunia, vaginal dryness, irritation, recurrent urinary tract infection and urinary incontinence, which negatively affect the patient's quality of life and sexuality. The purpose of this pilot study was to evaluate a protocol with topical growth factors that seeks to activate collagen and elastin at a molecular level, and thus restore all vaginal functions such as secretion, absorption, elasticity, lubrication and vaginal epithelium thickness.


Assuntos
Peptídeos e Proteínas de Sinalização Intercelular/administração & dosagem , Menopausa/efeitos dos fármacos , Doenças Vaginais/tratamento farmacológico , Administração Tópica , Atrofia , Dispareunia/tratamento farmacológico , Dispareunia/etiologia , Feminino , Genitália Feminina/efeitos dos fármacos , Humanos , Projetos Piloto , Qualidade de Vida , Vagina/efeitos dos fármacos , Vagina/patologia , Doenças Vaginais/fisiopatologia , Vulva/efeitos dos fármacos , Vulva/patologia
9.
Int Urogynecol J ; 30(5): 831-837, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-29971469

RESUMO

INTRODUCTION AND HYPOTHESIS: Genitourinary syndrome of menopause is a major health concern in postmenopausal women. This study was aimed at comparing the effect of a vitamin E vaginal suppository with that of conjugated estrogen vaginal cream on sexual function in postmenopausal women with genitourinary syndrome of menopause. METHODS: This survey was carried out on 52 postmenopausal women aged 40-65 years who had been referred to gynecology clinics in Mashhad city, during 2013-2014. Keeping ß = 0.1, the power was calculated to be 90%. The patients were randomly divided into two groups: vitamin E vaginal suppository and conjugated estrogen vaginal cream. Participants used the medications for 12 weeks. They were visited at the 4th, 8th, and 12th weeks. Validated Abbreviated Sexual Function Questionnaire (ASFQ), as the primary outcome measure, and a demographic information questionnaire, were used to collect data at each visit. Data were analyzed using SPSS and p < 0.05 was considered statistically significant. RESULTS: Mean overall scores of the ASFQ were increased significantly in both groups during the course of the study, compared with baseline (p < 0.001). However, the mean ASFQ scores of the two treatments did not differ significantly. CONCLUSION: Improved scores of ASFQ after the 12th week showed that the treatment was successful in both groups. Therefore, a vitamin E vaginal suppository may be an alternative to vaginal estrogen in relieving the symptoms of vaginal atrophy in postmenopausal women, especially those not able to use hormone therapy or have low compliance.


Assuntos
Antioxidantes/administração & dosagem , Atrofia/tratamento farmacológico , Pós-Menopausa , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Doenças Vaginais/tratamento farmacológico , Vitamina E/administração & dosagem , Administração Intravaginal , Adulto , Idoso , Estrogênios/administração & dosagem , Estrogênios Conjugados (USP)/administração & dosagem , Feminino , Humanos , Pessoa de Meia-Idade , Inquéritos e Questionários , Síndrome
10.
Maturitas ; 121: 86-92, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30509753

RESUMO

OBJECTIVE: To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA). METHODS: A structured search was carried out in PubMed-Medlin, Embase, Cochrane Controlled Trials Register databases through to 31 July 2018. The search included the following terms: "Ospemifene", "vulvovaginal atrophy", "dyspareunia", "SERM" and "randomized controlled trial" (RCTs). Four outcomes were selected: vaginal pH; proportions of parabasal and superficial vaginal cells; and perception of the most bothersome symptom (vaginal dryness or dyspareunia). A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool. RESULTS: Six RCTs comparing the efficacy of ospemifene against placebo after 12 and 52 weeks of treatment were included in the meta-analysis. At 12 weeks, changes in vaginal Ph (SMD: -0.96, 95% CI:-1.12 to -0.81; p < 0.0001), parabasal cells (SMD: -36.84 95% CI -46.95 to -26.72; p < 0.0001), superficial cells (SMD: 8.23, 95% CI 3.73-12.74, p < 0.0003), and dyspareunia (SMD= - 2.70, 95% CI - 2.88 to -2.52, p < 0.0001) indicated that ospemifene was more effective than placebo. CONCLUSION: The present meta-analysis suggests that ospemifene 60 mg is associated with significant improvement in the morphological and physiological features of the vaginal mucosa that correlate with the symptoms associated with postmenopausal VVA.


Assuntos
Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Tamoxifeno/análogos & derivados , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/tratamento farmacológico , Atrofia/tratamento farmacológico , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamoxifeno/uso terapêutico , Resultado do Tratamento , Vagina/patologia , Vulva/patologia
11.
Maturitas ; 121: 93-100, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30509754

RESUMO

OBJECTIVE: To evaluate the tolerability and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvo- vaginal atrophy (VVA). METHODS: The literature was searched through to 31 July 2018 to identify randomized controlled trials comparing ospemifene 60 mg against placebo for the treatment of VVA. Two groups of outcomes were selected: 1) side-effects, including hot flushes, urinary tract infection (UTI), headache, deep venous thrombosis (DVT), coronary heart disease (CHD), cardiovascular event (CVE), discontinuation due to side-effects, serious adverse event (SAE); 2) Safety, in relation to endometrial thickness, vaginal bleeding, breast tenderness, breast and endometrial cancer. A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool. RESULTS: In the group of patients treated with ospemifene, there was a slightly higher rate of hot flushes (OR:2.36, 95% CI 1.26-4.42; p = 0.007) and UTI (OR:1.97, 95% CI 1.23-3.14, p = 0.005) at 12 weeks of treatment, but no differences were noted after 52 weeks. The incidence of headaches, DVT, CHD, CVE, discontinuation of treatment, and SAEs was not significantly different between groups. Ospemifene treatment was statistically associated with a greater endometrial thickness in women with an intact uterus both at 12 weeks (SMD: 0.40, (95% CI 0.17 to 0.63, p < 0.0005) and at 52 weeks (SMD: 0.62, 95% CI 0.23-1.01, p = 0.002); however, this increase was not clinically relevant. The incidence of vaginal bleeding, endometrial cancer, breast tenderness, breast and endometrial cancer was not significantly different between groups. CONCLUSIONS: This meta-analysis suggests that ospemifene treatment is well tolerated and presents a good safety profile. Long-term safety studies with larger samples, which include patients at high risk, are warranted.


Assuntos
Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Tamoxifeno/análogos & derivados , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/tratamento farmacológico , Atrofia/tratamento farmacológico , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamoxifeno/uso terapêutico , Vagina/patologia , Vulva/patologia
12.
J Sex Med ; 15(12): 1776-1784, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30446472

RESUMO

INTRODUCTION: Vulvo-vaginal atrophy affects the daily lives of most post-menopausal women. We know that ospemifene intake can induce vaginal epithelial improvements within a few weeks; however, direct evidence of the effects of ospemifene on the human vulva and on connective tissue of both the vagina and vulva are lacking. AIM: To evaluate the changes induced by ospemifene on epithelium thickness, glycogen content proliferation index, collagen content, and type I/III collagen ratio in vulvar and vaginal tissue of post-menopausal women. METHODS: 20 women who attended our gynecologic clinic for planned surgery were recruited for the study. 11 subjects were taking ospemifene at the time of inclusion, and 9 subjects who were not taking ospemifene were selected as control group. Vaginal and vulvar biopsies were taken during surgery. Histological features and glycogen content were evaluated by standard hematoxylin-eosin and periodic acid-Schiff staining, total collagen and collagen type I/III ratio were evaluated by hydroxyproline assay and Sirius red staining, while the expression of Ki67 was evaluated by immunohistochemistry. MAIN OUTCOME MEASURE: We analyzed histological features of the epithelial and stromal layer of the vaginal and vulvar vestibule mucosa. RESULTS: Vaginal and vulvar biopsies from women taking ospemifene showed an increased epithelium thickness, glycogen content, and proliferation index compared with the control group. Collagen content was also higher in women taking ospemifene, while an increased ratio between type I and III collagen fibers was found only at vaginal level. CLINICAL IMPLICATIONS: Our study shows that the effectiveness of ospemifene on vaginal tissue also extends to the vulvar vestibule. STRENGTH & LIMITATIONS: This study provides direct evidence of the impact of ospemifene on vaginal and vulvar tissue. A specifically designed longitudinal study may further support our findings. CONCLUSION: Ospemifene intake is associated with a marked improvement of various morphological and physiological features of both vaginal and vulvar vestibule epithelium, including the collagen content of the tissues. Alvisi S, Baldassarre M, Gava G, et al. Structure of Epithelial and Stromal Compartments of Vulvar and Vaginal Tissue From Women With Vulvo-Vaginal Atrophy Taking Ospemifene. J Sex Med 2018;15:1776-1784.


Assuntos
Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Tamoxifeno/análogos & derivados , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/tratamento farmacológico , Atrofia/patologia , Tecido Conjuntivo/metabolismo , Epitélio/metabolismo , Feminino , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Tamoxifeno/uso terapêutico , Resultado do Tratamento , Doenças Vaginais/metabolismo , Doenças Vaginais/patologia , Vulva/patologia , Doenças da Vulva/metabolismo , Doenças da Vulva/patologia
13.
Dermatol Ther ; 31(6): e12678, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30411455

RESUMO

Vulvovaginal atrophy is a condition that affects women, although it is mainly associated with the onset of menopause mainly due to hormonal changes vulvovaginal laxity and mucosal atrophy can also affect women at different life stages such as after pregnancy or for cancer patients who have undergone chemo or endocrine therapy. This condition negatively influence quality of life, sexual desire, and self-confidence. Many therapies have been considered mainly with inconclusive or transient results in terms of benefit factor. Recently, a new non-invasive product, containing hyaluronic acid, oligopeptides, and antioxidants was introduced to the market. Its name is "Primavera," by Renaissance, Italy. The aim of this product is to allow a vulvo-vaginal biostimulation and considered simple, safe, and satisfactory.


Assuntos
Rejuvenescimento , Vagina/efeitos dos fármacos , Doenças Vaginais/tratamento farmacológico , Vulva/efeitos dos fármacos , Doenças da Vulva/tratamento farmacológico , Antioxidantes/efeitos adversos , Antioxidantes/uso terapêutico , Atrofia , Feminino , Humanos , Oligopeptídeos/efeitos adversos , Oligopeptídeos/uso terapêutico , Recuperação de Função Fisiológica , Resultado do Tratamento , Vagina/patologia , Vagina/fisiopatologia , Doenças Vaginais/patologia , Doenças Vaginais/fisiopatologia , Vulva/patologia , Vulva/fisiopatologia , Doenças da Vulva/patologia , Doenças da Vulva/fisiopatologia
14.
Menopause ; 25(11): 1339-1353, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30358731

RESUMO

OBJECTIVE: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM). METHODS: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. RESULTS: After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants. CONCLUSIONS: The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Desidroepiandrosterona/uso terapêutico , Dispareunia/tratamento farmacológico , Menopausa , Vagina/patologia , Doenças Vaginais/tratamento farmacológico , Vulva/patologia , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Administração Intravaginal , Adulto , Idoso , Idoso de 80 Anos ou mais , Atrofia/tratamento farmacológico , Desidroepiandrosterona/administração & dosagem , Desidroepiandrosterona/efeitos adversos , Método Duplo-Cego , Dispareunia/patologia , Feminino , Humanos , Concentração de Íons de Hidrogênio/efeitos dos fármacos , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Síndrome , Resultado do Tratamento , Sistema Urogenital/patologia , Vagina/química
15.
J Clin Endocrinol Metab ; 103(11): 4146-4154, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-30239842

RESUMO

Context: Intravaginal testosterone (IVT) is a potential treatment of vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use. Objective: To investigate the effects of IVT on sexual satisfaction, vaginal symptoms, and urinary incontinence (UI) associated with AI use. Design: Double-blind, randomized, placebo-controlled trial. Setting: Academic clinical research center. Participants: Postmenopausal women taking an AI with VVA symptoms. Intervention: IVT cream (300 µg per dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks. Main Outcomes and Measures: The primary outcome was the change in the sexual satisfaction score on the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function, the Female Sexual Distress Scale-Revised (FSDS-R), and the Questionnaire for UI Diagnosis. Serum sex steroids were measured. Results: A total of 44 women were randomly assigned and 37 provided evaluable data, (mean age 56.4 years, SD 8.8 years). At 26 weeks, the mean between-group difference in the baseline-adjusted change in FSFI satisfaction scores was significantly greater for the IVT group than the placebo group (mean difference 0.73 units; 95% CI, 0.02 to 1.43; P = 0.043). IVT cream resulted in significant improvements, compared with placebo, in FSDS-R scores (P = 0.02), sexual concerns (P < 0.001), sexual responsiveness (P < 0.001), vaginal dryness (P = 0.009), and dyspareunia (P = 0.014). Serum sex steroid levels did not change. Few women had UI symptoms, with no treatment effect. Conclusion: IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI among women on AI therapy merits further investigation.


Assuntos
Inibidores da Aromatase/efeitos adversos , Dispareunia/tratamento farmacológico , Testosterona/administração & dosagem , Incontinência Urinária/tratamento farmacológico , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Atrofia/induzido quimicamente , Atrofia/tratamento farmacológico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Método Duplo-Cego , Dispareunia/diagnóstico , Dispareunia/etiologia , Feminino , Humanos , Pessoa de Meia-Idade , Pós-Menopausa , Índice de Gravidade de Doença , Inquéritos e Questionários/estatística & dados numéricos , Resultado do Tratamento , Incontinência Urinária/diagnóstico , Incontinência Urinária/etiologia , Vagina/efeitos dos fármacos , Vagina/patologia , Cremes, Espumas e Géis Vaginais/administração & dosagem , Doenças Vaginais/induzido quimicamente , Doenças Vaginais/complicações , Doenças Vaginais/patologia , Vulva/efeitos dos fármacos , Vulva/patologia
16.
Curr Med Res Opin ; 34(12): 2131-2136, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30238814

RESUMO

OBJECTIVE: To review safety, efficacy and pharmacokinetic (PK) data from the phase 3 REJOICE trial, which evaluated a 17ß-estradiol (E2) softgel vaginal insert approved in 2018 for moderate to severe dyspareunia associated with menopausal vulvar and vaginal atrophy (VVA). METHODS: REJOICE (Clinicaltrials.gov: NCT02253173) was a randomized, double-blind, placebo-controlled trial in which women with moderate to severe dyspareunia due to menopausal VVA received 4 µg, 10 µg or 25 µg of an E2 vaginal insert or placebo for 12 weeks. The published data for the recently approved 4 µg and 10 µg doses of the E2 vaginal insert, including four co-primary efficacy endpoints (change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH and severity of dyspareunia), safety and PK (which included serum E2 levels measured by gas chromatography and tandem mass spectrometry), are summarized here. RESULTS: Women were randomized to receive the E2 vaginal insert (4 µg [n = 186] or 10 µg [n = 188]; Imvexxy a ) or placebo (n = 187) in the modified intention-to-treat population. The E2 vaginal insert (4 µg and 10 µg) significantly improved the percentages of superficial and parabasal cells (p < .0001), vaginal pH (p < .0001), and the severity score for dyspareunia (p < .05) from baseline to week 12 compared with placebo. The recently approved E2 vaginal insert was well tolerated, with no clinically significant differences in treatment-emergent or serious adverse events versus placebo. Systemic absorption of E2 with both doses was minimal. CONCLUSIONS: The recently FDA-approved E2 softgel vaginal insert (4 µg and 10 µg) was safe and effective over 12 weeks for treating moderate to severe dyspareunia due to menopausal VVA with minimal systemic E2 levels.


Assuntos
Dispareunia/tratamento farmacológico , Estradiol/administração & dosagem , Menopausa , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Adulto , Idoso , Atrofia , Ensaios Clínicos Fase III como Assunto , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Vagina/patologia , Vulva/patologia
17.
Complement Ther Med ; 39: 97-100, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30012400

RESUMO

OBJECTIVE: Besides conventional drugs, various vaginal disorders are often treated with complementary and alternative medicines. Different natural products are often used in treatment of genital infections. The aim is to present a case of treatment of vaginal infection with a garlic clove. METHODS: A detailed interview was conducted with the subject whose condition was described in this case. RESULTS: Young woman was diagnosed with vaginal Ureaplasma sp. infection. After failed local treatment with antibiotics and antifungals, subject obtained advice to treat the disorder with incised clove of garlic. Control examination by her gynecologist confirmed that infection was successfully cured. Subject experienced no adverse effects. CONCLUSIONS: Garlic clove successfully cured vaginal infection presented in this case. However, application to genital organs should be reserved for dosage forms, in order to prevent potential toxicity and to obtain reproducibility of active compounds concentrations.


Assuntos
Alho , Preparações de Plantas/uso terapêutico , Supositórios , Infecções por Ureaplasma/tratamento farmacológico , Doenças Vaginais/tratamento farmacológico , Adulto , Feminino , Humanos
19.
J Pediatr Adolesc Gynecol ; 31(5): 526-527, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29929016

RESUMO

BACKGROUND: Postoperative complications after transverse vaginal septum excision include stricture formation. The purpose of this report is to describe use of intralesional corticosteroid injections for vaginal strictures. CASE: A 32-year-old gravida 0 with history of transverse vaginal septum and recurrent strictures presented for follow-up of chronic pelvic pain. After her fourth septum revision, the patient underwent a total of 7 triamcinolone injections at the septum tissue. The course of triamcinolone injections improved the stricture and patient's pain. SUMMARY AND CONCLUSION: Steroid injection into the vaginal septum tissue can be a safe and effective adjuvant therapy after septum resection. Although it is an established adjuvant therapy in other specialties, further studies are warranted to show a decrease in the recurrence rate of vaginal strictures.


Assuntos
Constrição Patológica/tratamento farmacológico , Glucocorticoides/administração & dosagem , Triancinolona/administração & dosagem , Doenças Vaginais/tratamento farmacológico , Adulto , Constrição Patológica/etiologia , Feminino , Humanos , Injeções Intralesionais , Dor Pélvica/tratamento farmacológico , Dor Pélvica/etiologia , Complicações Pós-Operatórias/tratamento farmacológico , Recidiva , Vagina/patologia , Vagina/cirurgia , Doenças Vaginais/cirurgia
20.
Menopause ; 25(10): 1086-1093, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29738424

RESUMO

OBJECTIVE: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. METHODS: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 µg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. RESULTS: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence interval [CI] -0.5, 0.0; P = 0.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (-0.4 at 12 weeks; 95% CI -1.0, 0.1; P = 0.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI -0.1, 0.4; P = 0.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . CONCLUSIONS: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate-severe vulvovaginal symptoms.


Assuntos
Afeto/efeitos dos fármacos , Estradiol/administração & dosagem , Estradiol/uso terapêutico , Terapia de Reposição de Estrogênios/métodos , Pós-Menopausa/fisiologia , Qualidade de Vida , Cremes, Espumas e Géis Vaginais , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Idoso , Ansiedade/tratamento farmacológico , Depressão/tratamento farmacológico , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Inquéritos e Questionários , Resultado do Tratamento , Doenças da Vulva/tratamento farmacológico
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