Clinical trials: Vulvar Atrophy
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 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 Atrophy, Vulvovaginal Signs and Symptoms
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the…
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life
- Trial name
- STOPGSMP (NCT06962345)
- Testing
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Mucosa Innovations, S.L.
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
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.
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.
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
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
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 Atrophy
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia.
- Trial name
- NCT02966925
- Testing
- Cellular Matrix BCT-HA Kit
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Regen Lab SA
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
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
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