Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Drug: WC3011 Estradiol Vaginal Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455597

PR-04509

Details and patient eligibility

About

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Enrollment: 309 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed Study PR-04409.3 (NCT01400776)

Exclusion criteria

Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:

• Hypersensitivity to estrogen and/or progestin therapy
• Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
• Manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack
• Insulin-dependent diabetes mellitus
• Smoking ≥ 15 cigarettes daily
• Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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309 participants in 1 patient group

WC3011 Estradiol Vaginal Cream

Experimental group

Description:

WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.

Treatment:

Drug: WC3011 Estradiol Vaginal Cream