CompletedPhase 3

Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women

United States576 participantsStarted 2013-01-31

Plain-language summary

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 vaginal smear.

Who can participate

Age range35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent * Moderate to severe vaginal dryness * Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) \> 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH \> 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH \> 40 mIU/mL * Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years * Vaginal pH \>5.0 * Less than or equal 5% superficial cells on vaginal wall cytologic smear * Normal breast exam; if \> 40 years, documentation of negative mammogram Exclusion Criteria: * Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening * Smokes ≥ 15 cigarettes/day * Known or suspected premalignant or malignant disease * Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder * Increased frequency/severity headaches with estrogen therapy * Drug addiction/alcohol abuse within last 2 years * Currently taking St. John's Wort or anticoagulant * Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection

What they're measuring

Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in Vaginal pH to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Trial details

NCT IDNCT01816139

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11-19

Results submitted2022-04-11

View on ClinicalTrials.gov More Vulvovaginal Atrophy trials

Who can participate

Age range35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in Vaginal pH to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)