Clinical trials: Vulvovaginal Atrophy
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.
- Conditions
- Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms, Genitourinary Symptoms
- Trial name
- EPMLARF-arm1 (NCT04045379)
- Testing
- LASER, Microablative Radiofrequency, Estriol
- Where
- Brazil
- Volunteers
- 195 people
- Sponsor
- Federal University of São Paulo
Vulvovaginal Atrophy, Menopause
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Trial name
- NCT04210583
- Testing
- Vulvovaginal Treatment
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Venus Concept
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms.
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Breast Cancer, Vulvovaginal Atrophy, Genitourinary Syndrome of Menopause
- Trial name
- V-light cohort (NCT07563621)
- Testing
- Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R)
- Where
- Belgium
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Jessa Hospital
Menopause, Vaginal Atrophy
Vaginal Inflammation Markers in Postmenopausal Women With and Without Symptoms of Vaginal Inflammation
Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful intercourse. The underlying pathology is unknown.
- Trial name
- NCT01899612
- Where
- Switzerland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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.
Vulvovaginal Atrophy
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections.
- Trial name
- SYLIVA (NCT04219722)
- Testing
- Injection of DESIRIAL®
- Where
- 14 sites in Belgium, France
- Volunteers
- 121 people
- Sponsor
- Laboratoires Vivacy
Breast Cancer, Hot Flashes
Reproductive Health Survivorship Care Plan
The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS).
- Conditions
- Breast Cancer, Hot Flashes, Sexual Dysfunction, Fertility
- Trial name
- SCPR (NCT02667626)
- Testing
- Reproductive Health Survivorship Care Plan (SCPR), Control
- Where
- United States
- Volunteers
- 182 people
- Sponsor
- University of California, San Diego
Breast Cancer
Effects of Vaginal Estrogen on Serum Estradiol During Aromatase Inhibitor Therapy in Breast Cancer Patients with Vulvovaginal Atrophy: a Prospective Trial
Purpose: This study aimed to analyze changes in serum estradiol (E2) levels during concurrent vaginal estradiol therapy and adjuvant letrozole in postmenopausal breast cancer (BC) patients with vulvovaginal atrophy (VVA).
- Trial name
- NCT06654570
- Testing
- Intravaginal estrogen during adjuvant letrozole
- Where
- Finland
- Volunteers
- 20 people
- Sponsor
- Helsinki University Central Hospital
Vulvovaginal Atrophy
A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.
The goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.Hyaluronic acid and Estrogen were equally effective in vaginal treatment.
- Trial name
- NCT06144814
- Testing
- Hyaluronic acid vaginal gel, Estrogen vaginal use form
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Koru Health Groups
Breast Cancer
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment
Many studies have shown that locoregional treatment (surgery, radiotherapy) and systemic treatment (endocrine therapy and chemotherapy) for breast cancer (BC) may impact sexuality by causing physical and/or psychological damages.
- Trial name
- EPIONE-01 (NCT04713917)
- Testing
- Hyaluronique Acid Gel, Laser CO2, Hyaluronique Acid Injection
- Where
- France
- Volunteers
- 330 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sexual Dysfunction, Physiological, Body Image
Women's Interventions for Sexual Health: WISH
The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in…
- Conditions
- Sexual Dysfunction, Physiological, Body Image, Libido; Loss, Aversion
- Trial name
- WISH (NCT05692960)
- Testing
- Hypnotic Relaxation Intervention (HRI), Vulvovaginal Atrophy (VVA)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Tennessee, Knoxville
Vulvovaginal Atrophy, Menopause
Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women
The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA).
- Trial name
- NCT03281655
- Testing
- Visnadine, prenylflavonoids and bovine colostrum
- Volunteers
- 54 people
- Sponsor
- University of Messina
Vulvovaginal Atrophy
Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in…
- Trial name
- NCT04629885
- Testing
- Oxytocin 400 IU vaginal gel
- Where
- 3 sites in Sweden
- Volunteers
- 202 people
- Sponsor
- PepTonic Medical AB
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
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
Vulvovaginal Atrophy
Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
- Trial name
- CRETA (NCT04607707)
- Where
- 3 sites in Spain
- Volunteers
- 831 people
- Sponsor
- Shionogi
Vulvo-vaginal Atrophy, Genitourinary Syndrome of Menopause
New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue The aim of this study is to evaluate safety and…
- Trial name
- ViViA (NCT03857893)
- Testing
- Dynamic Quadripolar Radio-Frequency treatment, pH-Cream
- Where
- 5 sites in Belgium
- Volunteers
- 53 people
- Sponsor
- Serge Rozenberg
Atrophy, Vaginal Atrophy
Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects.
- Conditions
- Atrophy, Vaginal Atrophy, Genital Diseases, Female
- Trial name
- NCT02747641
- Testing
- Pixel CO2 Laser System
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alma Lasers Inc.
Vulvovaginal Atrophy, Menopause
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of…
- Conditions
- Vulvovaginal Atrophy, Menopause, Genitourinary Syndrome of Menopause
- Trial name
- NCT04746456
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Massachusetts General Hospital
Vulvovaginal Atrophy
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or…
- Trial name
- IDRA (NCT04766957)
- Testing
- Idracare
- Where
- 4 sites in Spain
- Volunteers
- 134 people
- Sponsor
- Procare Health Iberia S.L.