Clinical trials: Vaginal Atrophy
Atrophic Vaginitis
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the…
- Trial name
- NCT03294538
- Testing
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Where
- 44 sites in United States
- Volunteers
- 663 people
- Sponsor
- Actavis Inc.
Menopause
Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)
The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.
- Trial name
- TOTAL (NCT00431093)
- Testing
- tibolone, low-dose estradiol/noresterone
- Volunteers
- 570 people
- Sponsor
- Organon and Co
Vulvovaginal Atrophy
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and…
- Trial name
- NCT01816139
- Testing
- Vehicle, WC3011 Estradiol Vaginal Cream
- Where
- 48 sites in United States
- Volunteers
- 576 people
- Sponsor
- Warner Chilcott
Vaginal Atrophy in Breast Cancer Patients
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced…
- Trial name
- NCT03740945
- Testing
- Prasterone (DHEA)
- Sponsor
- EndoCeutics Inc.
Atrophic Vaginitis
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
- Trial name
- NCT05432154
- Testing
- Film forming silicone gel (7-0940)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stratpharma AG
Atrophic Vaginitis, Vaginal Disease
Evaluation of Gynecological Acceptability of 3 Health Care Products
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days.
- Trial name
- NCT04327947
- Testing
- Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2, Hyaluronic acid - Comparator product
- Where
- Brazil
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Herbarium Laboratorio Botanico Ltda
Vaginal Atrophy
Topical DHEA Against Vaginal Atrophy
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
- Trial name
- NCT01846442
- Testing
- DHEA (0.25%), DHEA (0.5%), DHEA (1.0%)
- Where
- 8 sites in United States, Canada
- Volunteers
- 218 people
- Sponsor
- EndoCeutics Inc.
Vulvovaginal Atrophy, Menopause
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Trial name
- NCT04210583
- Testing
- Vulvovaginal Treatment
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Venus Concept
Vulvar Atrophy, Vaginal Atrophy
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is…
- Trial name
- NCT01753102
- Testing
- Estradiol
- Where
- India
- Volunteers
- 49 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Atrophic Vaginitis Due to Menopause
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments…
- Trial name
- NCT01779947
- Testing
- Estradiol Vaginal Tablets 10 mcg
- Where
- 25 sites in United States
- Volunteers
- 519 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life.
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause (GSM), Quality of Life
- Trial name
- NCT07737782
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Mucosa Innovations, S.L.
Vulvovaginal Atrophy
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections.
- Trial name
- SYLIVA (NCT04219722)
- Testing
- Injection of DESIRIAL®
- Where
- 14 sites in Belgium, France
- Volunteers
- 121 people
- Sponsor
- Laboratoires Vivacy
Menopause, Postmenopausal Vaginal Atrophy
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
- Trial name
- NCT00465192
- Testing
- estradiol, 10 mcg, estradiol, 25 mcg
- Volunteers
- 230 people
- Sponsor
- Novo Nordisk A/S
Vulvar Atrophy
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
- Trial name
- DARE-VVA1 (NCT05378269)
- Testing
- Tamoxifen
- Where
- 2 sites in Australia
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Vaginal Atrophy
A Randomized Controlled Phase 2 Study to Determine Lowest Efficacious Dose of Ovestin in Vulvar and Vaginal Atrophy
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, dose-de-escalation study whose purpose is to establish the lowest efficacious dose.
- Trial name
- DOVE (NCT04159493)
- Testing
- Estriol
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aspen USA Inc
Postmenopausal Symptoms
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
- Trial name
- NCT00160173
- Testing
- Estrogel
- Where
- 109 sites in United States
- Volunteers
- 221 people
- Sponsor
- ASCEND Therapeutics
Atrophic Vaginitis
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02195986
- Testing
- Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream
- Where
- 21 sites in United States
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Atrophy Vulva
POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.
The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning…
- Trial name
- NCT06797167
- Testing
- Injections of a filler gel containing cross-linked hyaluronic acid
- Where
- Italy
- Volunteers
- 76 people
- Sponsor
- Rose Pharma SA
Atrophy, Vaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
- Trial name
- NCT01585558
- Testing
- Ospemifene (Dose 1), Ospemifene (Dose 2)
- Volunteers
- 180 people
- Sponsor
- Shionogi