Clinical trials: Vulvovaginal Atrophy
Vulvo Vaginal Atrophy
Regenerative Treatment of Female Genital Atrophy
Vulvovaginal health is a key aspect of active and healthy aging for all women. Hormonal deprivation that occurs during menopause significantly affects the anatomy and function of urogenital tissues, leading to their atrophy.
- Trial name
- RETREAT-FUGA (NCT07306611)
- Testing
- Mesotherapy with Autologous Platelet-Rich Plasma (PRP) to vulvovaginal area, Mesotherapy with saline solution, Platelet-Poor Plasma Gel
- Where
- Portugal
- Volunteers
- 30 people
- Sponsor
- AndreiaAntunes
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
Vulvovaginal Atrophy, Menopause
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia
- Trial name
- NCT02670785
- Testing
- Estradiol Vaginal Capsule (EVC)
- Where
- 20 sites in United States
- Volunteers
- 203 people
- Sponsor
- Warner Chilcott
Vulvovaginal Atrophy
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual…
- Trial name
- NCT02085980
- Testing
- Laser treatment
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- El. En. SpA
Atrophic Vaginitis, Menopause
Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues.
- Conditions
- Atrophic Vaginitis, Menopause, Vulvovaginal Atrophy
- Trial name
- NCT02460302
- Testing
- Vaginal progesterone
- Where
- Canada
- Sponsor
- Mount Sinai Hospital, Canada
Vulvovaginal Atrophy, Vasomotor Symptoms
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women
An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.
- Trial name
- NCT05418426
- Testing
- IVR Dose 1, IVR Dose 2, Oral Reference
- Where
- 2 sites in Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Vulvovaginal Atrophy, Urinary Incontinence
Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness
The goal of this clinical trial is to evaluate the combined application of BTL-785F and HPM-6000UF Devices in improving quality of life in women with negative changes in the urogenital system (vulvovaginal atrophy symptoms…
- Conditions
- Vulvovaginal Atrophy, Urinary Incontinence, Sexual Dysfunction
- Trial name
- NCT06846216
- Testing
- Treatment with BTL-785F and HPM-6000UF Devices
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Postmenopausal Vulvovaginal Atrophy
Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula…
- Trial name
- NCT04657536
- Testing
- high frequency fulguration equipment, promestriene vaginal soft capsules
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking University People's Hospital
Breast Cancer, Vulvovaginal Signs and Symptoms
WISH, Feasibility of a Factorial Design
The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
- Conditions
- Breast Cancer, Vulvovaginal Signs and Symptoms, Sexual Desire Disorder, Body Image
- Trial name
- NCT07023822
- Testing
- Hyaluronic acid (HLA) Vaginal Moisturizer, Polycarbophil Vaginal Moisturizer, Hypnotic Relaxation
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- The University of Tennessee, Knoxville
Postmenopausal Vulvovaginal Atrophy
A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy
This study is a phase III which includes two treatment phases. The phase 1 study is a multi-center, randomized, double-blind, placebo- controlled, parallel group that provide primary efficacy and safety data.
- Trial name
- NCT04982692
- Testing
- intravaginal prasterone
- Where
- China
- Volunteers
- 417 people
- Sponsor
- Lee's Pharmaceutical Limited
Vulvovaginal Atrophy
Vaginal Microbiota Among Postmenopausal Women
It is known that vaginal bacteria have an impact upon the health status of the host, in some cases protecting against infection and in other cases causing infection, depending on the bacterial types present.
- Trial name
- NCT01084616
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Vulvovaginal Atrophy
Performance and Safety of Class IIb MD Celegyn® in VVA
The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting…
- Trial name
- NCT03823560
- Testing
- Celegyn®
- Where
- 3 sites in Italy
- Volunteers
- 96 people
- Sponsor
- Nathura S.p.A
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
Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia
Randomized, Controlled Trial With Hybrid Fractional Laser
This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females
- Trial name
- NCT03647189
- Testing
- Hybrid Fractional Laser
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Sciton
Vulvovaginal Atrophy
High Tone Pelvic Floor Dysfunction
Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs in >50% of postmenopausal women.
- Trial name
- NCT03083262
- Testing
- no intervention
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- St. Louis University
Vulvovaginal Atrophy
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal…
- Trial name
- NCT04232813
- Testing
- Estradiol 10 MCG Vaginal Tablet [VAGIFEM], Promestriene Vaginal
- Where
- Spain
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Instituto Palacios
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
Vulvovaginal Atrophy
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and…
- Trial name
- NCT01816139
- Testing
- Vehicle, WC3011 Estradiol Vaginal Cream
- Where
- 48 sites in United States
- Volunteers
- 576 people
- Sponsor
- Warner Chilcott
Vaginal Atrophy in Breast Cancer Patients
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced…
- Trial name
- NCT03740945
- Testing
- Prasterone (DHEA)
- Sponsor
- EndoCeutics Inc.
Vulvovaginal Atrophy
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.
- Trial name
- NCT04887701
- Testing
- Non-hormonal vaginal device therapy
- Where
- 3 sites in Australia
- Volunteers
- 25 people
- Sponsor
- Madorra