Trial Outcomes & Findings for Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder (NCT NCT00611923)
NCT ID: NCT00611923
Last Updated: 2020-01-07
Results Overview
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.
COMPLETED
PHASE4
115 participants
Measured at Months 1and 2
2020-01-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
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.
|
Flutamide
n=13 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
n=5 Participants
|
36.3 years
n=7 Participants
|
35.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Months 1and 2Population: 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
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Flutamide
n=13 Participants
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.
|
|---|---|---|
|
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Month 1
|
-6.9 score on a scale
Standard Error 2.3
|
-5.5 score on a scale
Standard Error 2.1
|
|
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Month 2
|
-5.5 score on a scale
Standard Error 2.2
|
-8.3 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Measured at Months 1 and 2Population: 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
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Flutamide
n=12 Participants
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.
|
|---|---|---|
|
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale
Month 1
|
-21.3 score on a scale
Standard Error 5.3
|
-26.0 score on a scale
Standard Error 4.9
|
|
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale
Month 2
|
-22.2 score on a scale
Standard Error 7.5
|
-35.6 score on a scale
Standard Error 6.8
|
SECONDARY outcome
Timeframe: Measured at Months 1 and 2Population: 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
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
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Flutamide
n=13 Participants
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.
|
|---|---|---|
|
Side Effect Burden Measured by Side Effect Questionnaire
Month 1
|
3.9 score on a scale
Standard Error 1.4
|
3.5 score on a scale
Standard Error 1.3
|
|
Side Effect Burden Measured by Side Effect Questionnaire
Month 2
|
2.2 score on a scale
Standard Error 1.2
|
5.1 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Measured at Months 1 and 2Population: 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
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Flutamide
n=13 Participants
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.
|
|---|---|---|
|
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2
Month 1
|
3.2 score on a scale
Standard Error 0.3
|
2.5 score on a scale
Standard Error 0.3
|
|
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2
Month 2
|
3.1 score on a scale
Standard Error 0.3
|
2.2 score on a scale
Standard Error 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at Month 1 and Month 2Population: 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
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Flutamide
n=13 Participants
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.
|
|---|---|---|
|
Change in Clinical Global Severity Scale
Month 1
|
-0.9 score on a scale
Standard Error 0.4
|
-1.2 score on a scale
Standard Error 0.4
|
|
Change in Clinical Global Severity Scale
Month 2
|
-0.5 score on a scale
Standard Error 0.4
|
-1.7 score on a scale
Standard Error 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at Month 1 and Month 2Population: 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
Scale range in 1-7. 1 is very much improved, 4 is no change, and 7 is very much worse.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Flutamide
n=12 Participants
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.
|
|---|---|---|
|
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
Month 1
|
3.0 score on a scale
Standard Error 0.3
|
2.4 score on a scale
Standard Error 0.3
|
|
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
Month 2
|
2.2 score on a scale
Standard Error 0.3
|
3.1 score on a scale
Standard Error 0.3
|
Adverse Events
Placebo
Flutamide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
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.
|
Flutamide
n=13 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 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.
|
15.4%
2/13 • Number of events 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.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
18.2%
2/11 • Number of events 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.
|
23.1%
3/13 • Number of events 3 • 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.
|
|
Vascular disorders
hot flushes
|
0.00%
0/11 • 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.
|
15.4%
2/13 • Number of events 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.
|
|
Nervous system disorders
headache
|
9.1%
1/11 • Number of events 1 • 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.
|
38.5%
5/13 • Number of events 5 • 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.
|
|
Nervous system disorders
parasthesia
|
0.00%
0/11 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/11 • 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.
|
30.8%
4/13 • Number of events 4 • 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.
|
|
Gastrointestinal disorders
nausea
|
18.2%
2/11 • Number of events 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.
|
15.4%
2/13 • Number of events 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.
|
|
Gastrointestinal disorders
constipation
|
18.2%
2/11 • Number of events 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.
|
0.00%
0/13 • 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.
|
|
Nervous system disorders
insomnia
|
18.2%
2/11 • Number of events 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.
|
15.4%
2/13 • Number of events 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.
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
0.00%
0/11 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
dry mouth
|
0.00%
0/11 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Nervous system disorders
fatigue
|
0.00%
0/11 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
Additional Information
Margaret Altemus
Weill Cornell Medical College and Yale School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place