Clinical trials: Vaginal Atrophy
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
Atrophic Vaginitis, Breast Cancer
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness.
- Trial name
- NCT00984399
- Testing
- Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Atrophy
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
- Trial name
- NCT02770365
- Testing
- estrace cream (Perrigo), estrace cream (Reference)
- Where
- United States
- Volunteers
- 695 people
- Sponsor
- Padagis LLC
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Atrophic Vaginitis
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02995694
- Testing
- Estradiol, Reference
- Volunteers
- 535 people
- Sponsor
- Alvogen Pine Brook LLC
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
Vaginal Atrophy, Postmenopausal Symptoms
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors
The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone.
- Conditions
- Vaginal Atrophy, Postmenopausal Symptoms, Breast Cancer Female, Long-term Survivors
- Trial name
- NCT04493333
- Testing
- Vaginal Dehydroepiandrosterone, Vaginal Polycarbophil Moisturizer
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Arkansas
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
Atrophic Vaginitis
A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse.
- Trial name
- NCT00816556
- Testing
- Estriol, Estradiol valerate, Vanicream Lite
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Maire Mac Bride
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
Atrophy, Vaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
- Trial name
- NCT01585558
- Testing
- Ospemifene (Dose 1), Ospemifene (Dose 2)
- Volunteers
- 180 people
- Sponsor
- Shionogi
Breast Cancer, Vaginal Dryness
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs).
- Conditions
- Breast Cancer, Vaginal Dryness, Dyspareunia, Sexual Health Quality of Life
- Trial name
- NCT01697345
- Testing
- Testosterone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Creighton University
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Safety of Ospemifene
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
- Trial name
- NCT00566982
- Testing
- Ospemifene 60 mg
- Volunteers
- 426 people
- Sponsor
- Shionogi
Vaginal Atrophy
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the…
- Trial name
- NCT03493126
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Ohio State University
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
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
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
Vaginal Atrophy
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.