MenopausePhase 2NCT00990886
The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
A Phase 2 study testing Oxybutynin chloride in people with Menopause and Hot Flashes, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Oxybutynin chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: The Effect of Ditropan XL on Vasomotor Symptoms in Healthy Postmenopausal Women: a Double-blind Placebo Controlled Pilot Study
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.
Read the 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.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Placebo, Oxybutynin chloride
- Keywords
- Oxybutynin, Ditropan, Menopause Treatment, Vasomotor symptoms, Hot Flashes, Non-hormonal therapy for Vasomotor symptoms
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Once daily for 12 weeks
Oxybutynin chlorideDrug
15 mg once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Oxybutynin chloride 15 mg once daily for 12 weeks Receives: Drug: Oxybutynin chloride |
| 002 | Placebo comparator | Placebo Once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Weeks 4 and 12
Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12
Measured: Weeks 4 and 12
Change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12
Measured: Weeks 4 and 12
Change in daily frequency of any hot flashes from baseline to Week 4 and Week 12
Measured: Weeks 4 and 12
Subject Global Assessment (SGA) score
Measured: Administer at baseline and weekly; assess at weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startApr 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990886
- Sponsor's protocol ID
- CR002878
- Other IDs
- CAPSS 300
- Status last verified
- Dec 2012
- First submitted
- 18 Sep 2009
- Last updated
- 12 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ditropan XL on Vasomotor Symptoms in Healthy Postmenopausal Women: a Double-blind Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00990886
- Acronym / sponsor ID
- CR002878
- Conditions
- Menopause, Hot Flashes
- Keywords
- Oxybutynin, Ditropan, Menopause Treatment, Vasomotor symptoms, Hot Flashes, Non-hormonal therapy for Vasomotor symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Oxybutynin chlorideOxybutynin chloride 15 mg once daily for 12 weeks |
| 002 | Placebo comparator | Drug: PlaceboPlacebo Once daily for 12 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOnce daily for 12 weeks | Drug | 002 |
| Oxybutynin chloride15 mg once daily for 12 weeks | Drug | 001 |
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.
Time frame: Week 12 in the study corresponds to visit 6 that is scheduled from day 78 to day 84.
5 secondary outcomes
Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12
Time frame: Weeks 4 and 12
Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12
Time frame: Weeks 4 and 12
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
Change in daily frequency of any hot flashes from baseline to Week 4 and Week 12
Time frame: Weeks 4 and 12
Subject Global Assessment (SGA) score
Time frame: Administer at baseline and weekly; assess at weeks 4 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxybutynin chloride in people with Menopause and Hot Flashes, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.