Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women (VENUS)

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Vulvovaginal Atrophy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01400776

PR-04409.3

Details and patient eligibility

About

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Enrollment: 722 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion criteria

• 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, congestive heart failure, stroke or ischemic attacks
• Insulin-dependent diabetes mellitus
• Increased frequency or severity of headaches while on hormone or estrogen therapy
• Drug or alcohol addiction within last 2 years
• Participation in a clinical trial within 30 days
• Smoking ≥ 15 cigarettes daily
• Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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722 participants in 4 patient groups, including a placebo group

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Experimental 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

Vehicle (2 Times/Week)

Placebo Comparator group

Description:

Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.

Treatment:

Drug: Vehicle

WC3011 Estradiol Vaginal Cream (3 Times/Week)

Experimental group

Description:

WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.

Treatment:

Drug: WC3011 Estradiol Vaginal Cream

Vehicle (3 Times/Week)

Placebo Comparator group

Description:

Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.

Treatment:

Drug: Vehicle