A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
1 other identifier
interventional
203
1 country
20
Brief Summary
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2016
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2016
CompletedAugust 23, 2017
August 1, 2017
9 months
January 12, 2016
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Change in the percentage of vaginal superficial cells
Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells
Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH
Baseline (Week 0) to Final Visit (Week 6)
Secondary Outcomes (8)
Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale
Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom
Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom
Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dysuria
Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal and/or vulvar irritation/itching
Baseline (Week 0) to Final Visit (Week 6)
- +3 more secondary outcomes
Study Arms (4)
Estradiol Vaginal Capsule 0.003 mg
EXPERIMENTALAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.01 mg
EXPERIMENTALAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.02 mg
EXPERIMENTALAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Placebo
PLACEBO COMPARATORAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Interventions
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of vulvovaginal atrophy due to post menopause
- Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
- Moderate to severe vaginal dryness
- Normal breast exam; if \> 40 years
- Vaginal pH \> 5.0
- \< 5% superficial cells on vaginal wall cytology smear
You may not qualify if:
- Known hypersensitivity to estrogen and/or progestin therapy
- Known or suspected premalignant or malignant disease
- Undiagnosed abnormal genital bleeding
- A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
- Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
- Increased frequency/severity headaches with estrogen therapy
- Smokes ≥ 15 cigarettes/day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (20)
Visions Clinical Research-Tucson
Tucson, Arizona, 85712, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Fellows Research Alliance, Inc
Savannah, Georgia, 31406, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Office of R. Garn Mabey, M.D.
Las Vegas, Nevada, 89128, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Women's Health Research
Columbus, Ohio, 43213, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Fellows Research Alliance, Inc
Bluffton, South Carolina, 29910, United States
Radiant Research, Inc.
Dallas, Texas, 75231, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
Virginia Women's Center
Richmond, Virginia, 23233, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
North Spokane Women's Clinic
Spokane, Washington, 99207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vilma Sniukiene, MD
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
February 2, 2016
Study Start
February 15, 2016
Primary Completion
November 14, 2016
Study Completion
November 14, 2016
Last Updated
August 23, 2017
Record last verified: 2017-08