The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women

Summary

The objective of this study is to evaluate the safety and efficacy of extended-release oxybutynin chloride for the treatment of vasomotor symptoms, also known as hot flashes, in healthy naturally postmenopausal women. This is a randomized, double-blind, multi-center, parallel group, placebo-controlled study evaluating the safety and efficacy of extended-release oxybutynin chloride on hot flashes in healthy naturally postmenopausal women. Patients will be randomized to extended-release oxybutynin chloride or placebo in a 1:1 ratio. The total duration of the study for each treatment group is approximately 98 days. Patients will be seen for their Pre-Randomization Visit (Visit 1) fourteen (14) days prior to randomization and a physical examination, medical history, hot flash history, vital signs and laboratory tests will be performed. Patients will also have daily diaries dispensed to record their hot flashes (frequency for each severity). Patients who meet the eligibility criteria for this study will be randomized at Visit 2. At this visit, patients will have vital signs taken, adverse events recorded, study medication dispensed, and complete Quality of Life (QOL) questionnaires. The patient will be instructed to start her study medication beginning the morning after this visit (defined as Study Day 1). In both treatment groups, patients will return for follow-up visits between Study Days 8-14 (Visit 3), 22-28 (Visit 4), and 50-56 (Visit 5). The Final Study Visit (Visit 6) will occur between Study Days 78-84.

Timeline

Start

2004-04

Primary completion

2005-01

Completion

2005-01

Drugs

Indications

No indication recorded.