Status:
COMPLETED
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Lead Sponsor:
Warner Chilcott
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief 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 whe...
Eligibility Criteria
Inclusion
- 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
- 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-dependent diabetes mellitus
- Increased frequency or severity of headaches while on hormone or estrogen therapy
- Currently taking St. John's Wort
- Drug/alcohol addiction within past 2 years
- Treatment with anticoagulants (heparin or warfarin)
- Smoking ≥15 cigarettes/day
Key Trial Info
Start Date :
April 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2013
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT01845649
Start Date
April 12 2013
End Date
November 20 2013
Last Update
May 9 2022
Active Locations (57)
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1
Warner Chilcott Investigational Study Site
Birmingham, Alabama, United States, 35211
2
Warner Chilcott Investigational Study Site
Mobile, Alabama, United States, 36608
3
Warner Chilcott Investigational Study Site
Chandler, Arizona, United States, 85224
4
Warner Chilcott Investigational Study Site
Phoenix, Arizona, United States, 85032