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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
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual Dysphoric Disorder, PMDD, PMS

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 6, 2008
    Last Updated
    December 18, 2019
    Sponsor
    Weill Medical College of Cornell University
    Collaborators
    National Institute of Mental Health (NIMH)
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    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

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