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 range

35 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

35 Years

Sex

FEMALE

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)