Clinical trials: Vulvovaginal Atrophy
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
Menopause
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal…
- Trial name
- NCT00361569
- Testing
- DR-2041a, DR-2041b
- Where
- 97 sites in United States
- Volunteers
- 622 people
- Sponsor
- Duramed Research
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
Vaginal Atrophy
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel…
- Trial name
- NCT02967510
- Testing
- Estriol
- Where
- 23 sites in Czechia, Hungary and 3 more
- Volunteers
- 283 people
- Sponsor
- ITF Research Pharma, S.L.U.
Postmenopausal Vulvovaginal Atrophy
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
- Trial name
- VENUS (NCT01400776)
- Testing
- WC3011 Estradiol Vaginal Cream, Vehicle
- Where
- 70 sites in United States
- Volunteers
- 722 people
- Sponsor
- Warner Chilcott
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
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
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
- Trial name
- NCT01845649
- Testing
- WC3011 Estradiol Vaginal Cream, Vehicle
- Where
- 57 sites in United States
- Volunteers
- 550 people
- Sponsor
- Warner Chilcott
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
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
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
Vulvovaginal Atrophy
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
- Trial name
- NCT01455597
- Testing
- WC3011 Estradiol Vaginal Cream
- Where
- 64 sites in United States
- Volunteers
- 309 people
- Sponsor
- Warner Chilcott
Vulvovaginal Atrophy, Vasomotor Symptoms
Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women
Randomized, Open-label 2-arm, parallel group study in approximately 20 healthy postmenopausal women to assess the safety of DARE-HRT1 Intravaginal Rings in two different dose strengths and the PK of progesterone and estradiol…
- Trial name
- DARE-HRT1 (NCT05367973)
- Testing
- IVR Dose 1, IVR Dose 2
- Where
- 2 sites in Australia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
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.
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
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the…
- Trial name
- NCT02013544
- Testing
- Prasterone (DHEA)
- Where
- 38 sites in United States, Canada
- Volunteers
- 558 people
- Sponsor
- EndoCeutics Inc.