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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00990886
First received: September 18, 2009
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Menopause
Hot Flashes
Drug: Placebo
Drug: Oxybutynin chloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ditropan XL on Vasomotor Symptoms in Healthy Postmenopausal Women: a Double-blind Placebo Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • 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. [ Time Frame: Week 12 in the study corresponds to visit 6 that is scheduled from day 78 to day 84. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12 [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12 [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12 [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Change in daily frequency of any hot flashes from baseline to Week 4 and Week 12 [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Subject Global Assessment (SGA) score [ Time Frame: Administer at baseline and weekly; assess at weeks 4 and 12 ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: April 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Oxybutynin chloride 15 mg once daily for 12 weeks
Drug: Oxybutynin chloride
15 mg once daily for 12 weeks
Placebo Comparator: 002
Placebo Once daily for 12 weeks
Drug: Placebo
Once daily for 12 weeks

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- and post- study physical examinations, laboratory analysis, adverse events and vital signs. The primary endpoints in this study are the change in daily frequency of moderate to severe hot flushes from baseline to Week 12 (corresponding to visit 6 that is scheduled from day 78 to day 84) and the change in severity of moderate to severe hot flushes from baseline to Week 12. Daily severity score of moderate to severe hot flashes is the sum of all moderate hot flashes times 2 and all severe hot flashes (including waking episodes) times 3 divided by the total number of moderate to severe hot flashes on that day. Baseline severity is the average of all daily severity scores in the 14 days before the first dose of study medication. Week 12 severity is the average of all daily severity scores in the 7 days before Visit 6 or the 7 days including and before the last double-blind dose if subject withdraws before Visit 6. The baseline value for daily frequency is defined as total number of moderate to severe hot flashes recorded during pre-randomization period divided by the number of days in the corresponding period for which complete diaries are received. The daily frequency for Week 12 is defined as the total number of moderate to severe hot flashes recorded during the last 7 days prior to last dose of study medication divided by the number of days in that week for which complete diaries are received. The secondary endpoints include change in daily frequency of moderate to severe hot flashes from baseline to Week 4, change in severity of moderate to severe hot flashes from baseline to Week 4, change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12, change in daily frequency of any hot flashes from baseline to Week 4 and Week 12, change in severity of any hot flash from baseline to Week 4 and Week 12, and change in daily composite score of any hot flashes from baseline to Week 4 and Week 12. Other secondary endpoints include all scores from the Profile of Mood States, Pittsburgh Sleep Quality Index, Menopause-Specific Quality of Life Questionnaire, Short Form-36 Health Survey, and Sleep Disruption Scale, as well as the Patient Global Assessment score. Patients were dispensed a diary at the Pre-Randomization Visit (Visit 1) and started to record their hot flashes (frequency for each severity). The term hot flash is descriptive of a sudden onset of reddening of the skin over the head, neck, and chest, accompanied by a feeling of intense body heat and concluded by sometimes profuse perspiration. The duration varies from a few seconds to several minutes and, rarely, for an hour. The severity of a hot flash was defined as:1. Mild: sensation of heat without sweating; 2. Moderate: sensation of heat with sweating, able to continue activity; 3. Severe: sensation of heat with sweating, causing cessation of activity. Waking episodes (i.e., episodes that wake the patient from sleep) associated with hot flashes were recorded separately and were considered severe. Patients will receive either extended-release oxybutynin chloride, 15 mg or matching placebo. One tablet will be taken orally every day in the morning for 12 weeks.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990886

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00990886     History of Changes
Other Study ID Numbers: CR002878, CAPSS 300
Study First Received: September 18, 2009
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Oxybutynin
Ditropan
Menopause Treatment
Vasomotor symptoms
Hot Flashes
Non-hormonal therapy for Vasomotor symptoms

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Mandelic Acids
Oxybutynin
Anti-Infective Agents
Anti-Infective Agents, Urinary
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Renal Agents
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014