Status:
COMPLETED
The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Menopause
Hot Flashes
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief 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 post...
Detailed Description
A total of approximately 140 women will be recruited into the study (70 patients in the extended-release oxybutynin chloride group and 70 patients in the placebo group). Safety will be assessed by pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00990886
Start Date
April 1 2004
End Date
January 1 2005
Last Update
December 12 2012
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