Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Upsher-Smith Laboratories

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Symptoms

Treatments: Drug: Divigel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00727129

P04-001

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Enrollment: 495 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women
• Have moderate to severe hot flashes
• Normal Pap Smear

Exclusion criteria

• Abnormal mammogram
• Abnormal clinical breast exam
• BMI >35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind