CompletedPhase 2

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

148 participantsStarted 2004-04

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 nor…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The co-primary endpoints in this study are the change in daily frequency of moderate to severe hot flashes from baseline to Week 12 and the change in severity of moderate to severe hot flashes from baseline to Week 12.

Timeframe: Week 12 in the study corresponds to visit 6 that is scheduled from day 78 to day 84.

Trial details

NCT IDNCT00990886

SponsorOrtho-McNeil Janssen Scientific Affairs, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-01

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