Clinical trials: Vulvovaginal Atrophy
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.
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
Vulvovaginal Atrophy, Menopause
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Trial name
- REJOICE (NCT02253173)
- Testing
- Estradiol
- Where
- 105 sites in United States, Canada
- Volunteers
- 764 people
- Sponsor
- TherapeuticsMD
Vulvovaginal Atrophy, Dyspareunia
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks.
- Trial name
- NCT02784613
- Testing
- Ospemifene
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sue Goldstein
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
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
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.
Female Urogenital Diseases, Breast Cancer Female
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer.
- Trial name
- NCT05585476
- Testing
- C02 microablative laser, Regenerative topical treatment
- Where
- Spain
- Volunteers
- 195 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM)
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.
- Conditions
- Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients, Vaginal Atrophy Patients With GSM
- Trial name
- NCT06828640
- Testing
- vaginal dilators
- Where
- Belgium
- Volunteers
- 160 people
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
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
Vulvo Vaginal Atrophy
Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors
Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e.
- Trial name
- NCT06922136
- Testing
- Hyalo Gyn Vaginal Gel
- Where
- 7 sites in Italy
- Volunteers
- 156 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Stress Urinary Incontinence, Sexual Dysfunction
Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
This is an open label, prospective study aimed to evaluate safety and efficacy of the Silk'n Tightra device for improvement of sexual functioning, vulvovaginal appearance and reduction of SUI.
- Conditions
- Stress Urinary Incontinence, Sexual Dysfunction, Vulvovaginal Atrophy
- Trial name
- NCT03900143
- Testing
- Tightra vaginal device
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Home Skinovations Ltd.
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.
Menopause, Genitourinary Syndrome of Menopause
Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal…
- Conditions
- Menopause, Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Menopause Syndrome
- Trial name
- NCT03782480
- Testing
- Intrarosa
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Center for Vulvovaginal Disorders
Vaginal Dryness
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal…
- Trial name
- NCT02638337
- Testing
- Ospemifene
- Volunteers
- 631 people
- Sponsor
- Shionogi
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
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
Hot Flashes
Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.
- Trial name
- NCT00391417
- Testing
- estradiol gel
- Volunteers
- 431 people
- Sponsor
- BioSante Pharmaceuticals
Dyspareunia
Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia
Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks.
- Trial name
- NCT03568604
- Testing
- Prasterone
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- San Diego Sexual Medicine
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