Premenstrual SyndromePhase 4NCT00611923
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
A Phase 4 study testing Flutamide in people with Premenstrual Syndrome, run by Weill Medical College of Cornell University.
Trial summary
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Flutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: Androgen Hormones in PMDD
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Flutamide, Placebo
- Keywords
- Premenstrual Dysphoric Disorder, PMDD, PMS
- Medical subject headings
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutamideDrug
Also called Eulexin
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Participants will take placebo flutamide Receives: Drug: Placebo |
| A | Experimental | Participants will take flutamide Receives: Drug: Flutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Months 1and 2
Secondary outcomes (3)
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: 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: 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: Measured at Months 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startFeb 2005
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Margaret Altemus, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611923
- Sponsor's protocol ID
- R34MH072878
- Other IDs
- R34MH072878, DATR A5-ETPD
- Status last verified
- Dec 2019
- First submitted
- 6 Feb 2008
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Hormones in PMDD
- ClinicalTrials.gov ID
- NCT00611923
- Acronym / sponsor ID
- R34MH072878
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Dysphoric Disorder, PMDD, PMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Drug: PlaceboParticipants will take placebo flutamide |
| A | Experimental | Drug: FlutamideParticipants will take flutamide |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlutamideAlso: EulexinParticipants 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. | Drug | A |
| PlaceboParticipants 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. | Drug | B |
Primary outcome
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Time frame: Measured at Months 1and 2
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.
3 secondary outcomes
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale
Time frame: Measured at Months 1 and 2
Side Effect Burden Measured by Side Effect Questionnaire
Time frame: Measured at Months 1 and 2
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2
Time frame: Measured at Months 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Premenstrual Syndrome
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Altemus, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flutamide in people with Premenstrual Syndrome, run by Weill Medical College of Cornell University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS) (time frame: Measured at Months 1and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.