Clinical trials: Menopause and Genitourinary Syndrome
Urge Incontinence, Urgency-frequency Syndrome
The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function
This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.
- Trial name
- NCT05391425
- Testing
- no intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Istanbul University
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
Genitourinary Syndrome of Menopause
Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy
We have recently developed and optimized a vaginal Optical Coherence tomography/angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina…
- Trial name
- NCT04737616
- Testing
- CO2 laser, OCT
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Irvine
Genitourinary Syndrome of Menopause (GSM)
CO₂ Laser With or Without Platelet-Rich Plasma for Genitourinary Syndrome of Menopause
This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM).
- Trial name
- NCT07863739
- Testing
- Fractional CO₂ Laser, Autologous Platelet-Rich Plasma (PRP)
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- National and Kapodistrian University of Athens
Bacterial Vaginosis, Candidiasis
Vaginal Ecosystem and Network in the United States Study
The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions.
- Conditions
- Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause
- Trial name
- VENUS (NCT06472765)
- Testing
- Vaginal Swab Collection
- Where
- 21 sites in United States, Canada
- Volunteers
- 3,250 people, healthy volunteers welcome
- Sponsor
- Vaginal Biome Science
Vulvovaginal Atrophy
Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles.
- Trial name
- NCT04487392
- Testing
- Estrogen vaginal cream group (group A), Photobiomodutation group (group B)
- Sponsor
- University of Nove de Julho
HIV Infection, Vaginal Atrophy
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural…
- Conditions
- HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions
- Trial name
- NCT04079218
- Testing
- Estradiol Vaginal Insert
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kerry Murphy
Women With Breast Cancer
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause…
- Trial name
- PROPOSE (NCT06611514)
- Testing
- Prasterone (DHEA)
- Where
- Italy
- Volunteers
- 95 people
- Sponsor
- European Institute of Oncology
Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause
Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders
Ospemifene is the first oral and non-hormonal treatment for moderate or severe vulvo-vaginal atrophy (VVA) in postmenopausal women who are not candidates to treatment with local oestrogens.
- Conditions
- Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Sexual; Disorder, Arousal, Female
- Trial name
- EROS (NCT04677491)
- Testing
- Ospemifene 60 mg, fMRI experiments
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Hospital Clinic of Barcelona
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
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.
Overactive Bladder Syndrome, Urinary Incontinence, Urge
Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women
The goal of this clinical trial is to learn if surface tibial electrical stimulation (mild electrical signals on the inside of the ankle) helps women 60 years or older with urine leakage that happens on the way to the bathroom or…
- Conditions
- Overactive Bladder Syndrome, Urinary Incontinence, Urge, Nocturia
- Trial name
- TTNS (NCT06617676)
- Testing
- Transcutaneous tibial nerve stimulation
- Volunteers
- 60 people
- Sponsor
- Louisiana State University Health Sciences Center Shreveport
Genitourinary Syndrome of Menopause
Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize
The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation…
- Trial name
- Caress (NCT06879938)
- Testing
- High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid, hyaluronic acid-based gel (Hydeal-D®)
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Breast Cancer, Genitourinary Syndrome of Menopause
CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer
Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies…
- Trial name
- NCT04517370
- Testing
- Fractional/Pixel CO2 laser
- Where
- Israel
- Volunteers
- 36 people
- Sponsor
- Hadassah Medical Organization
Atrophic Vaginitis, Menopause
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.
- Trial name
- VeLVET (NCT02691936)
- Testing
- CO2 fractionated vaginal laser, Estrogens, Conjugated (USP)
- Where
- 6 sites in United States
- Volunteers
- 69 people
- Sponsor
- The Cleveland Clinic
Female Sexual Function, Vulvovaginal Atrophy
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
This clinical trial, a double blind randomized controlled trial, is conducted to determine the effects of daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women…
- Conditions
- Female Sexual Function, Vulvovaginal Atrophy, Postmenopausal Atrophic Vaginitis
- Trial name
- NCT04579991
- Testing
- Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel, Emulgel-only
- Where
- Thailand
- Volunteers
- 100 people
- Sponsor
- Chulalongkorn University
Menopause, Platelet-rich Plasma
Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems.
- Conditions
- Menopause, Platelet-rich Plasma, Estrogen Replacement Therapy, Vaginal Atrophy
- Trial name
- NCT05483634
- Testing
- Vaginal estrogen supplement, Platelet-rich plasma injection
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Mackay Memorial Hospital
Vaginal Atrophy
Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause.
- Trial name
- NCT03754205
- Testing
- Microablative Fractional CO2 laser
- Where
- Greece
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
Menopause, Vaginal Atrophy
CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause
Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness…
- Conditions
- Menopause, Vaginal Atrophy, Urinary Incontinence
- Trial name
- NCT03939078
- Testing
- CO2 fractional ablative laser
- Where
- Brazil
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Universidade Federal Fluminense
HIV Infections
Sex, Aging and Antiretroviral Pharmacokinetics
The purpose of this research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal.
- Trial name
- NCT00666055
- Testing
- ARV regimen chosen by treating physician
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Kristine Patterson, MD