CompletedPhase 3

Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

United States722 participantsStarted 2011-06-29

Plain-language summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

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: * Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness Exclusion Criteria: * Hypersensitivity to estrogen and/or progestin therapy * Known or suspected premalignant or malignant disease (except successfully treated skin cancers) * Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks * Insulin-dependent diabetes mellitus * Increased frequency or severity of headaches while on hormone or estrogen therapy * Drug or alcohol addiction within last 2 years * Participation in a clinical trial within 30 days * Smoking ≥ 15 cigarettes daily * Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

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 Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Vaginal pH to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Trial details

NCT IDNCT01400776

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02-27

Results submitted2022-04-11

View on ClinicalTrials.gov More Postmenopausal 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 Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Vaginal pH to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit

Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit

Timeframe: Baseline (Day 0) to Week 12/Final Visit