Clinical trials: Vaginal Atrophy
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
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
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
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
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
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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
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
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Atrophic Vaginitis
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the…
- Trial name
- NCT03294538
- Testing
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Where
- 44 sites in United States
- Volunteers
- 663 people
- Sponsor
- Actavis Inc.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg…
- Trial name
- NCT00630539
- Testing
- Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
- Volunteers
- 126 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
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
Atrophic Vaginitis
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02195986
- Testing
- Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream
- Where
- 21 sites in United States
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
Vaginal Atrophy
A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in…
- Trial name
- BLISSAFE (NCT02413008)
- Testing
- estriol
- Where
- 6 sites in Spain, Sweden
- Volunteers
- 61 people
- Sponsor
- ITF Research Pharma, S.L.U.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
- Trial name
- NCT00276094
- Testing
- Ospemifene 30 mg, Ospemifene 60 mg, Nonhormonal vaginal lubricant
- Volunteers
- 826 people
- Sponsor
- Shionogi
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.
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
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.