Clinical trials: Vulvar and Vaginal Atrophy
Vaginal Atrophy
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01358760
- Testing
- DHEA
- Where
- 42 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- EndoCeutics Inc.
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.
Postmenopausal Symptoms
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
- Trial name
- NCT00727129
- Testing
- Divigel
- Volunteers
- 495 people
- Sponsor
- Upsher-Smith Laboratories
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
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
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
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
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.
Vaginal Atrophy
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
- Trial name
- NCT00238732
- Testing
- Bazedoxifene/Conjugated Estrogen
- Where
- 63 sites in United States
- Volunteers
- 650 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
- Trial name
- NCT00276094
- Testing
- Ospemifene 30 mg, Ospemifene 60 mg, Nonhormonal vaginal lubricant
- Volunteers
- 826 people
- Sponsor
- Shionogi
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
Vulvar and Vaginal Atrophy
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients…
- Trial name
- NCT03332303
- Testing
- Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
- Where
- 27 sites in United States
- Volunteers
- 540 people
- Sponsor
- Prasco LLC
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg…
- Trial name
- NCT00630539
- Testing
- Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
- Volunteers
- 126 people
- Sponsor
- Shionogi
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.
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
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 Atrophy, Vulvar Atrophy
VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH >…
- Trial name
- NCT00453089
- Testing
- VG101
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bionovo
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.
Vulvar and Vaginal Atrophy
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk…
- Trial name
- NCT02668796
- Testing
- Estradiol Vaginal Tablets 10 mcg (Glenmark), Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
- Where
- United States
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- Glenmark Pharmaceuticals Ltd. India