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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• Patients must be in good health

• Must be naturally postmenopausal and have not experienced menses for at least 6 months prior to the start of the study

• Must have serum FSH levels > 40 mIU/mL

• Must average seven or more moderate to severe hot flushes with sweating per day, based upon data obtained from a completed diary for the 14 consecutive days between pre-randomization and Visit 2

• Must have read and signed the informed consent after the nature of the study has been fully explained and received a copy to take home

• Must be highly motivated to complete the study according to protocol requirements

• Must read, write and communicate in English

Exclusion Criteria:

• Patients who are currently using an anticholinergic agent

• Are at significant risk of developing complete urinary retention if placed on an anticholinergic agent

• Have undergone a bilateral oophorectomy with or without a hysterectomy

• Have used the following medications within two weeks of the Pre-Randomization Visit (Visit 1): Dopaminergic or antidopaminergic drugs

• Clonidine

• Digitalis preparations

• Psychotropic medication including antidepressants (e.g. selective serotonin reuptake inhibitors)

• hypnotic sedatives and tranquilizers

• Narcotic analgesics unless approved by monitor

• Chronic use (> 14 consecutive days) of antihistamines

• Antiepileptics (e.g. neurontin)

• Herbal supplements used to relieve hot flushes

• Belladonna alkaloids

• Patients with a TSH below the normal range

• with uncontrolled narrow angle glaucoma, obstructive uropathy, myasthenia gravis, and/or advanced pelvic organ prolapsed

• Any of the following gastrointestinal (GI) problems: History of partial or complete obstruction, narrowing (pathological or iatrogenic) of the gastrointestinal tract, decreased GI motility, such as paralytic ileus, intestinal atony, or chronic or severe constipation, those at risk of gastric retention

• Patients with a known allergy or hypersensitivity to oxybutynin or components of the dosage form

• Patients with a current drug or alcohol abuse problem as judged by the investigator