Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret Altemus, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00611923
First received: February 6, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Premenstrual Syndrome
Drug: Flutamide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Androgen Hormones in PMDD

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Months 2 and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily Rating of Severity of Problems (DRSP) Scale [ Time Frame: Measured at Months 2 and 4 ] [ Designated as safety issue: No ]
  • Side Effect Questionnaire [ Time Frame: Measured at Months 2 and 4 ] [ Designated as safety issue: Yes ]
  • Clinical Global Improvement Scale [ Time Frame: Measured at Months 2 and 4 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2005
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Participants will take placebo flutamide
Drug: 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.
Experimental: A
Participants will take flutamide
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.
Other Name: Eulexin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611923

Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Margaret Altemus, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Margaret Altemus, Associate Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00611923     History of Changes
Other Study ID Numbers: R34 MH072878, R34MH072878, DATR A5-ETPD
Study First Received: February 6, 2008
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Premenstrual Dysphoric Disorder
PMDD
PMS

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Flutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014