Clinical trials: Vaginal Atrophy
Menopause, Vulvovaginal Atrophy
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and…
- Conditions
- Menopause, Vulvovaginal Atrophy, Painful Intercourse, Dyspareunia
- Trial name
- NCT02449902
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- TherapeuticsMD
Vulvovaginal Atrophy
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
- Trial name
- NCT01845649
- Testing
- WC3011 Estradiol Vaginal Cream, Vehicle
- Where
- 57 sites in United States
- Volunteers
- 550 people
- Sponsor
- Warner Chilcott
Atrophy
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
- Trial name
- NCT02770365
- Testing
- estrace cream (Perrigo), estrace cream (Reference)
- Where
- United States
- Volunteers
- 695 people
- Sponsor
- Padagis LLC
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Atrophic Vaginitis
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02995694
- Testing
- Estradiol, Reference
- Volunteers
- 535 people
- Sponsor
- Alvogen Pine Brook LLC
Menopause
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal…
- Trial name
- NCT00361569
- Testing
- DR-2041a, DR-2041b
- Where
- 97 sites in United States
- Volunteers
- 622 people
- Sponsor
- Duramed Research
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
Postmenopausal Vulvovaginal Atrophy
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
- Trial name
- VENUS (NCT01400776)
- Testing
- WC3011 Estradiol Vaginal Cream, Vehicle
- Where
- 70 sites in United States
- Volunteers
- 722 people
- Sponsor
- Warner Chilcott
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
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Safety of Ospemifene
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
- Trial name
- NCT00566982
- Testing
- Ospemifene 60 mg
- Volunteers
- 426 people
- Sponsor
- Shionogi
Vaginal Dryness
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal…
- Trial name
- NCT02638337
- Testing
- Ospemifene
- Volunteers
- 631 people
- Sponsor
- Shionogi
Vaginal Atrophy
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.
Vaginal Atrophy
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
- Trial name
- NCT01256671
- Testing
- DHEA
- Where
- 41 sites in United States, Canada
- Volunteers
- 530 people
- Sponsor
- EndoCeutics Inc.
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
Vulvovaginal Atrophy
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
- Trial name
- NCT01455597
- Testing
- WC3011 Estradiol Vaginal Cream
- Where
- 64 sites in United States
- Volunteers
- 309 people
- Sponsor
- Warner Chilcott
Vaginal Atrophy
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel…
- Trial name
- NCT02967510
- Testing
- Estriol
- Where
- 23 sites in Czechia, Hungary and 3 more
- Volunteers
- 283 people
- Sponsor
- ITF Research Pharma, S.L.U.
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.
Dyspareunia
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
- Trial name
- NCT05617820
- Testing
- Estradiol, Imvexxy
- Where
- 48 sites in United States, El Salvador and 1 more
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Atrophic Vaginitis
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer…
- Trial name
- Gynoflor (NCT01370551)
- Testing
- Estriol 0.03 mg, lyophylized lactobacillus
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 16 people
- Sponsor
- Medinova AG
Vulvovaginal Atrophy, Menopause
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Trial name
- REJOICE (NCT02253173)
- Testing
- Estradiol
- Where
- 105 sites in United States, Canada
- Volunteers
- 764 people
- Sponsor
- TherapeuticsMD