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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH072878 | U.S. NIH Grant/Contract | View source | |
| DATR A5-ETPD |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Placebo Comparator | Participants will take placebo flutamide |
|
| A | Experimental | Participants will take flutamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutamide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at Months 1and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Severity Scale | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Altemus, MD | Weill Medical College of Cornell University | Principal Investigator |
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115 subjects enrolled in the screening phase of the study. 27 subjects qualified for randomization and 25 of those agreed to participate in the treatment study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants will take placebo flutamide Placebo: 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. |
| FG001 | Flutamide | Participants will take flutamide Flutamide: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants will take placebo flutamide Placebo: 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. |
| BG001 | Flutamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided PMTS ratings. At the two month visit 10 subjects taking placebo and 11subjects randomized to flutamide provided PMTS ratings | Posted | Mean | Standard Error | score on a scale | Measured at Months 1and 2 |
|
2 months per subject
One subject randomized to placebo never took the medication after it was dispensed, so is not included in the adverse event table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | SNOWMED | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Altemus | Weill Cornell Medical College and Yale School of Medicine | 646-209-6277 | maltemus@med.cornell.edu |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D005485 | Flutamide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Placebo | Drug | 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. |
|
| Measured at Months 1 and 2 |
| 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 | Measured at Months 1 and 2 |
| 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. | Measured at Months 1 and 2 |
| Measured at Month 1 and Month 2 |
| 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 | Scale range in 1-7. 1 is very much improved, 4 is no change, and 7 is very much worse. | Measured at Month 1 and Month 2 |
Participants will take flutamide Flutamide: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Flutamide | Flutamide: 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. |
|
|
|
| Secondary | 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. | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 10 subjects taking placebo and 12 subjects taking flutamide provided DRSP ratings. At the two month visit 10 subjects taking placebo and 12 subjects randomized to flutamide provided DRSP ratings | Posted | Mean | Standard Error | score on a scale | Measured at Months 1 and 2 |
|
|
|
|
| Secondary | 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 | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided side effect ratings. At the two month visit 10 subjects taking placebo and 10 subjects randomized to flutamide provided side effect ratings | Posted | Mean | Standard Error | score on a scale | Measured at Months 1 and 2 |
|
|
|
|
| Secondary | 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. | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide had CGI-improvement ratings. At the two month visit 10 subjects taking placebo and 12 subjects randomized to flutamide had CGI-improvement ratings | Posted | Mean | Standard Error | score on a scale | Measured at Months 1 and 2 |
|
|
|
|
| Other Pre-specified | Change in Clinical Global Severity Scale | 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. | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided CGI severity ratings. At the two month visit 10 subjects taking placebo and 11subjects randomized to flutamide provided CGI severity ratings | Posted | Mean | Standard Error | score on a scale | Measured at Month 1 and Month 2 |
|
|
|
|
| Other Pre-specified | 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 | Scale range in 1-7. 1 is very much improved, 4 is no change, and 7 is very much worse. | 12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 12 subjects taking flutamide had Patient Global Improvement Scale ratings. At the two month visit 10 subjects taking placebo and 11 subjects randomized to flutamide had Patient Global Improvement Scale ratings | Posted | Mean | Standard Error | score on a scale | Measured at Month 1 and Month 2 |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 7 |
| 11 |
| EG001 | Flutamide | Flutamide: 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. | 0 | 13 | 0 | 13 | 11 | 13 |
| dry skin | Skin and subcutaneous tissue disorders | SNOWMED | Non-systematic Assessment |
|
| hot flushes | Vascular disorders | SNOWMED | Systematic Assessment |
|
| headache | Nervous system disorders | SNOWMED | Non-systematic Assessment |
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| parasthesia | Nervous system disorders | SNOWMED | Non-systematic Assessment |
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| stomach pain | Gastrointestinal disorders | SNOWMED | Systematic Assessment |
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| nausea | Gastrointestinal disorders | SNOWMED | Systematic Assessment |
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| constipation | Gastrointestinal disorders | SNOWMED | Systematic Assessment |
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| insomnia | Nervous system disorders | SNOWMED | Systematic Assessment |
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| leg pain | Musculoskeletal and connective tissue disorders | SNOWMED | Systematic Assessment |
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| dry mouth | Skin and subcutaneous tissue disorders | SNOWMED | Systematic Assessment |
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| fatigue | Nervous system disorders | SNOWMED | Systematic Assessment |
|
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000588 |
| Amines |
| t-test, 2 sided |
| = 0.2 |
| Superiority or Other (legacy) |
| Month 2 |
|
|
| Superiority or Other (legacy) |
| Month 2 |
|
|
| t-test, 2 sided |
| = .05 |
| Superiority or Other (legacy) |
| Month 2 |
|
|
| <.04 |
| Superiority or Other (legacy) |
paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups |
| Month 2 |
|
|
| =0.06 |
| Superiority or Other (legacy) |
paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups |