Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

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

Completed

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Key information

Conditions

Postmenopausal Symptoms Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Postmenopausal women
Have moderate to severe hot flashes
Normal Pap Smear

Exclusion criteria

Abnormal mammogram
Abnormal clinical breast exam
BMI >35

Treatment and study plan

Divigel

Drug

Primary outcomes

Daily frequency and severity of moderate to severe vasomotor symptoms

Secondary outcomes

vulvar and vaginal atrophy

Sponsors and collaborators

Lead sponsor

Upsher-Smith Laboratories

Industry

Registry information

Official study title

Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Important dates

Study start: 2004
Study completion: 2005
First posted: Aug 1, 2008
Registry last updated: Sep 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed