CompletedPhase 3

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

United States550 participantsStarted 2013-04-12

Plain-language summary

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.

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: * Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA) * Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) \>40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH \>40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH \>40 mIU/mL * Age ≥40 years; ≥35 with bilateral oophorectomy * Vaginal pH \>5.0 * Less than or equal to 5% superficial cells on vaginal wall cytologic smear * Normal clinical breast exam or negative mammogram if ≥ 40 years of age * Negative urine pregnancy test (non-hysterectomized and \<12 months amenorrhea) Exclusion Criteria: * Enrollment in Sponsor's Study PR-04409 or PR-05812 * Participation in clinical trial or use of investigational drug within 30 days prior to screening * Known hypersensitivity to estrogen and/or progestin therapy * Known or suspected premalignant or malignant disease or history steroid-dependent malignancy * Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or \>50% angiographic narrowing of coronary artery * Thrombophlebitis or thromboembolic disorder or history of * Insulin-dependen…

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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) 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 IDNCT01845649

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11-20

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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) 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)