Clinical trials: Vulvar and Vaginal Atrophy
Atrophic Vaginitis Due to Menopause
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments…
- Trial name
- NCT01779947
- Testing
- Estradiol Vaginal Tablets 10 mcg
- Where
- 25 sites in United States
- Volunteers
- 519 people
- Sponsor
- Amneal Pharmaceuticals, LLC
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
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
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
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
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, 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
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.
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
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