The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
Information source: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menopause; Hot Flashes
Intervention: Placebo (Drug); Oxybutynin chloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
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.
Clinical Details
Official title: The Effect of Ditropan XL on Vasomotor Symptoms in Healthy Postmenopausal Women: a Double-blind Placebo Controlled Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12 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 Subject Global Assessment (SGA) score
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
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women.
Starting date: April 2004
Last updated: December 11, 2012
|