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

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Drug: Vehicle; Drug: WC3011 Estradiol Vaginal Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01816139

PR-05812

Details and patient eligibility

About

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 self-assessment, vaginal pH and vaginal smear.

Enrollment: 576 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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576 participants in 2 patient groups, including a placebo group

Vehicle (2 Times/Week)

Experimental group

Description:

Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Treatment:

Drug: Vehicle

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Placebo Comparator group

Description:

WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Treatment:

Drug: WC3011 Estradiol Vaginal Cream