Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
NCT ID: NCT05098574
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2023-02-03
2024-04-11
Brief Summary
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Lay Summary:
This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians.
One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Yaz
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Placebo
Continuous treatment with placebo for 12 weeks
Placebo
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
Interventions
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Yaz
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Placebo
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of BD (clinically euthymic) according to the DSM-5
* Diagnosis of PMDD according to the DSM-5
* Regular menstrual cycles
* No contraindication to use oral contraceptives
* Capable of consent for treatment
Exclusion Criteria
* Current or recent (last month) use of systemic estrogen or progesterone treatment
* Severe reactions to hormone treatment
* Pregnant or breastfeeding
* Current substance use disorder
* Oophorectomy or hysterectomy
* Current unstable medical conditions
* History of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.
16 Years
45 Years
FEMALE
No
Sponsors
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Hamilton Academic Health Sciences Organization
OTHER
McMaster University
OTHER
St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Benicio Frey
Psychiatrist/ Professor
Principal Investigators
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Benicio N Frey, MD, MSc,PhD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Locations
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St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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Ma S, Song SJ. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2023 Jun 23;6(6):CD006586. doi: 10.1002/14651858.CD006586.pub5.
Other Identifiers
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BDPMDD01
Identifier Type: -
Identifier Source: org_study_id
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