Study to Evaluate Safety & Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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 subject self-assessment when compared to vehicle.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe & most bothersome symptom of VVA (vulvovaginal atrophy)

• Postmenopausal & 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

• Normal clinical breast exam or negative mammogram if ≥ 40 years of age

• Negative urine pregnancy test (non-hysterectomized & <12 months amenorrhea

Exclusion Criteria:

• Enrollment 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 &/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