Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

Premenstrual Syndrome Clinical Trial

Official title:

Androgen Hormones in PMDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611923
• Other study ID #: R34MH072878
• Secondary ID: R34MH072878DATR
• Status: Completed
• Phase: Phase 4
• Start date: February 2005
• Est. completion date: December 2011

Study information

• Verified date: December 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder
• Premenstrual Syndrome

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Measured at Month 1 and Month 2
Other	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
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.	Measured at Months 1and 2
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.	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	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.	Measured at Months 1 and 2