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

NCT00990886 | Completed Phase 2

• 2 other identifiers: CR002878CAPSS 300
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Menopause; Hot Flashes

Keywords

Oxybutynin; Ditropan; Menopause Treatment; Vasomotor symptoms; Hot Flashes; Non-hormonal therapy for Vasomotor symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12

  Weeks 4 and 12

• Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12

  Weeks 4 and 12

• Change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12

  Weeks 4 and 12

• Change in daily frequency of any hot flashes from baseline to Week 4 and Week 12

  Weeks 4 and 12

• Subject Global Assessment (SGA) score

  Administer at baseline and weekly; assess at weeks 4 and 12

Study Arms (2)

001

EXPERIMENTAL

Oxybutynin chloride 15 mg once daily for 12 weeks

Drug: Oxybutynin chloride

002

PLACEBO COMPARATOR

Placebo Once daily for 12 weeks

Drug: Placebo

Interventions

Placebo DRUG

Once daily for 12 weeks

002

Oxybutynin chloride DRUG

15 mg once daily for 12 weeks

001

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Related Links

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

MeSH Terms

Conditions

Hot Flashes

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: October 7, 2009
• Study Start: April 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: December 12, 2012

Record last verified: 2012-12