Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Flutamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual Dysphoric Disorder, PMDD, PMS
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for PMDD by history
- Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry
- Willing to use barrier methods of birth control during the study if sexually active
- If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study
- Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry
Exclusion Criteria:
- Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry
- Suicide attempt or severe suicidal ideation within the 2 years prior to study entry
- History of any psychotic disorder or bipolar disorder
- Substance abuse, except nicotine, within the 6 months prior to study entry
- Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry
- Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry
- Use of sleeping pills more than once per week
- Consumption of more than 50 ounces of alcohol per week
- Pregnant or breastfeeding
- Hepatic, renal, autoimmune, or chronic inflammatory disease
- Seizure disorder
- Inability to read or follow instructions in English
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
B
A
Arm Description
Participants will take placebo flutamide
Participants will take flutamide
Outcomes
Primary Outcome Measures
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Low score on PMTS scale is 0 and high score is 40. Change score is calculated as PMTS score at month 1 or month 2 minus baseline PMTS score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.
Secondary Outcome Measures
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale
DRSP low score is 21 high score is 126. High score indicates more severe symptoms. Average score for the 4 days preceding menses was calculated for each subject in each cycle. Change score is calculated as DRSP score at month 1 or month 2 minus baseline DRSP score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.
Side Effect Burden Measured by Side Effect Questionnaire
The Side Effects Questionnaire is a measure of combined side effect burden, including a score for frequency (0-6), intensity (0-6) and interference with function (0-6). Low score is 0, high score is 18, High score represents greater severe side effect burden
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2
Scale range in 1-7. 1 is very much improved compared to baseline, 4 is no change compared to baseline, and 7 is very much worse compared to baseline.
Full Information
NCT ID
NCT00611923
First Posted
February 6, 2008
Last Updated
December 18, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00611923
Brief Title
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Official Title
Androgen Hormones in PMDD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Detailed Description
Premenstrual dysphoric disorder (PMDD) is a condition that affects about 5% of menstruating women. Women with PMDD experience serious emotional and physical disturbances, which may include depression, tension, irritability, anger, anxiety, and sleep and appetite problems. Symptoms of PMDD are directly linked with the menstrual cycle, generally beginning in the latter half of the cycle and ending around the start of the next cycle. If left unmanaged, PMDD may interfere with a woman's ability to carry out normal day-to-day functioning. Current treatments for PMDD include medications, psychotherapy, and nutritional modifications. Flutamide, a medication that blocks the action of testosterone and other mood-influencing hormones, may be helpful in alleviating symptoms of PMDD. This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
This two-phase study will last a total of 4 months and will include 7 study visits. Phase 1 will last 2 months and will include Visits 1 through 3. During Phase 1, participants will keep a daily record of symptoms, participate in a diagnostic interview, and undergo a medical history review, a physical exam, and screening laboratory tests. Eligible participants will then enter Phase 2, the treatment phase of the study.
During the treatment phase, participants will be randomly assigned to take flutamide or placebo for 2 months. Study visits will occur every 2 weeks and will include Visits 4 through 7. These visits will include discussion of side effects, symptom rating, and laboratory tests to check for pregnancy and any side effects related to liver function, blood counts, or blood chemistry. At the end of treatment with flutamide or placebo, participants will have the option of receiving treatment with sertraline, an antidepressant known to be effective for many women with PMDD. Sertraline will be given during the 2 premenstrual weeks for two cycles. If participants have already unsuccessfully tried sertraline for PMDD treatment, an alternative treatment can be attempted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Dysphoric Disorder, PMDD, PMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Participants will take placebo flutamide
Arm Title
A
Arm Type
Experimental
Arm Description
Participants will take flutamide
Intervention Type
Drug
Intervention Name(s)
Flutamide
Other Intervention Name(s)
Eulexin
Intervention Description
Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
Primary Outcome Measure Information:
Title
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Description
Low score on PMTS scale is 0 and high score is 40. Change score is calculated as PMTS score at month 1 or month 2 minus baseline PMTS score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.
Time Frame
Measured at Months 1and 2
Secondary Outcome Measure Information:
Title
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale
Description
DRSP low score is 21 high score is 126. High score indicates more severe symptoms. Average score for the 4 days preceding menses was calculated for each subject in each cycle. Change score is calculated as DRSP score at month 1 or month 2 minus baseline DRSP score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.
Time Frame
Measured at Months 1 and 2
Title
Side Effect Burden Measured by Side Effect Questionnaire
Description
The Side Effects Questionnaire is a measure of combined side effect burden, including a score for frequency (0-6), intensity (0-6) and interference with function (0-6). Low score is 0, high score is 18, High score represents greater severe side effect burden
Time Frame
Measured at Months 1 and 2
Title
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2
Description
Scale range in 1-7. 1 is very much improved compared to baseline, 4 is no change compared to baseline, and 7 is very much worse compared to baseline.
Time Frame
Measured at Months 1 and 2
Other Pre-specified Outcome Measures:
Title
Change in Clinical Global Severity Scale
Description
Scale range in 1-7. 1 is not at all ill, 4 is moderately ill, and 6 is severely ill and 7 is among the most extremely ill patients. Change score is calculated as Clinical Global Severity Scale score at the end of treatment month 1 or treatment month 2 minus baseline score. Negative change score is a reduction in symptoms during treatment and a positive change score is an increase in symptoms during treatment.
Time Frame
Measured at Month 1 and Month 2
Title
Change in Premenstrual Symptoms as Measured by the Patient Global Premenstrual Symptoms as Measured by the Patient Global Improvement Scale at Month 1 and Month 2
Description
Scale range in 1-7. 1 is very much improved, 4 is no change, and 7 is very much worse.
Time Frame
Measured at Month 1 and Month 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV criteria for PMDD by history
Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry
Willing to use barrier methods of birth control during the study if sexually active
If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study
Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry
Exclusion Criteria:
Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry
Suicide attempt or severe suicidal ideation within the 2 years prior to study entry
History of any psychotic disorder or bipolar disorder
Substance abuse, except nicotine, within the 6 months prior to study entry
Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry
Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry
Use of sleeping pills more than once per week
Consumption of more than 50 ounces of alcohol per week
Pregnant or breastfeeding
Hepatic, renal, autoimmune, or chronic inflammatory disease
Seizure disorder
Inability to read or follow instructions in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Altemus, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
We'll reach out to this number within 24 hrs