Clinical trials: Vulvar 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
Vulvar Atrophy, Vaginal Atrophy
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen.
- Trial name
- VVA PAP POPQ (NCT07024667)
- Testing
- Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Hillel Yaffe Medical Center
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
Bacterial Vaginosis, Candida Albicans Vulvovaginitis
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
- Conditions
- Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis, Trichomonas Vaginitis
- Trial name
- NCT04219605
- Where
- Israel
- Volunteers
- 226 people
- Sponsor
- Meir Medical Center
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
Vulvar Diseases, Vulvar Atrophy
Vulvar Disease in Nigeria Observational Study
Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria
- Conditions
- Vulvar Diseases, Vulvar Atrophy, Dermatoses
- Trial name
- VdiN (NCT05890092)
- Testing
- Observation
- Where
- United Kingdom
- Volunteers
- 1,000 people
- Sponsor
- KDRS ltd
Atrophic Vaginitis, Vaginal Atrophy
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term…
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva
- Trial name
- VALOR (NCT05953090)
- Testing
- 7-0940
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Stratpharma AG
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
Vulvar Atrophy
Clinical Study on the Safety and Efficacy of an Injectable Hyaluronic Acid for Improving the Aesthetic Rejuvenation of the Vulvovaginal Area
This prospective, single-center, before-after study evalutated BtH Intimate 2.0%, a cross-linked hyaluronic acid injectable used to restore volume and improve the aesthetic appearance and hydration of the vulvovaginal area in…
- Trial name
- NCT07402395
- Testing
- BtHIntimate® Injectable Hyaluronic Acid Treatment
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- i+Med S.Coop.
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 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
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
Vaginal Atrophy, Genitourinary Syndrome of Menopause
The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.
- Conditions
- Vaginal Atrophy, Genitourinary Syndrome of Menopause, Vulvar Atrophy
- Trial name
- NCT06514586
- Testing
- Oxytocin, Hydroxypropyl methylcellulose
- Where
- Egypt
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Oxagon
Genitourinary Syndrome of Menopause
Natural Topical Treatment for Vulvar and Vaginal Atrophy
Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.
- Trial name
- NCT05871255
- Testing
- Zantogin® Gel
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Dr. Amjad Khan
Vulvar Atrophy
Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections.
- Trial name
- ESOLANE (NCT04147689)
- Testing
- DESIRIAL® PLUS
- Where
- 9 sites in France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Laboratoires Vivacy
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
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