Clinical trials: Vulvar Atrophy
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
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
Sexual Pain Disorders, Postmenopausal Symptoms
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source…
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction
- Trial name
- NCT03682601
- Testing
- 5% sinecatechins ointment, 10% sinecatechins ointment
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GTO Pharmaceutical, LLC
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
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
Dyspareunia, Menopause
Genital Laser Treatment in Postmenopausal Patients
Regulation of sexual functions without hormonal support in order to correct the sexual dysfunctions in women with the estrogen hormone lost in the menopausal process.
- Conditions
- Dyspareunia, Menopause, Sexual Activity, Atrophy Vulva
- Trial name
- NCT05631665
- Testing
- Survey results before and after laser treatment
- Where
- Turkey (Türkiye)
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Menopausal Urethral Atrophy, Vulvar Atrophy
Laser Vaginal Treatment for GSM
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life.
- Trial name
- NCT04042766
- Testing
- laser vaginal treatment
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
Vulvovaginal Atrophy
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain.
- Trial name
- ROSA (NCT04898556)
- Testing
- Prasterone 6.5 MG
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dr. Santiago Palacios
Menopause
The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health
This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., psychological, somatic, urogenital symptoms) and on bone health in…
- Trial name
- MPS (NCT04001088)
- Testing
- Probiotic
- Where
- 5 sites in United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
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
Vaginal Dryness, Vaginal Atrophy
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area.
- Conditions
- Vaginal Dryness, Vaginal Atrophy, Vulvar Dryness, Vulvar Atrophy
- Trial name
- NCT02937805
- Testing
- Moisturizing vaginal and vulvar sea buckthorn oil cream, Moisturizing vaginal and vulvar cream
- Where
- Finland
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Petra Larmo
Vagina Atrophy
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
- Trial name
- NCT04511260
- Testing
- NuEra Tight VRF Handpiece
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lumenis Be Ltd.
Vulvar Atrophy
Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women…
- Trial name
- NCT06333782
- Testing
- Experimental- Genefill Contour®, Marketed comparator - Desirial®Plus
- Where
- 3 sites in France, Poland
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Bioscience Cosmetics SL
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, 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