Status:
COMPLETED
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
Lead Sponsor:
Warner Chilcott
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief 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 sel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2013
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT01816139
Start Date
January 31 2013
End Date
November 19 2013
Last Update
May 9 2022
Active Locations (48)
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1
Warner Chilcott Investigational Study Site
Huntsville, Alabama, United States, 35801
2
Warner Chilcott Investigational Study Site
Mobile, Alabama, United States, 36608
3
Warner Chilcott Investigational Study Site
Phoenix, Arizona, United States, 85032
4
Warner Chilcott Investigational Study Site
Scottsdale, Arizona, United States, 85251