This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. 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.
Age range
16 Years – 45 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Feasibility outcome: treatment compliance
Timeframe: 12 weeks
Feasibility outcome: retention rates
Timeframe: 12 weeks
Feasibility outcome: recruitment rate (monthly)
Timeframe: 2 years
Feasibility outcome: recruitment capacity
Timeframe: 2 years
Feasibility outcome: screening rates (monthly)
Timeframe: 2 years
Feasibility outcome: duration of assessment process
Timeframe: Screening
Feasibility outcome: duration of assessment process
Timeframe: Baseline
Feasibility outcome: duration of assessment process
Timeframe: Week 4
Feasibility outcome: duration of assessment process
Timeframe: Week 8
Feasibility outcome: duration of assessment process
Timeframe: Week 12
Feasibility outcome: safety of use of oral contraceptives in this population
Timeframe: Week 4
Feasibility outcome: safety of use of oral contraceptives in this population
Timeframe: Week 8
Feasibility outcome: safety of use of oral contraceptives in this population
Timeframe: Week 12
Feasibility outcome: tolerability
Timeframe: Week 4
Feasibility outcome: tolerability
Timeframe: Week 8
Feasibility outcome: tolerability
Timeframe: Week 12
Feasibility outcome: response rates
Timeframe: Week 12
Feasibility outcome: estimated treatment effect
Timeframe: Week 12
Feasibility outcome: variance of the treatment effect
Timeframe: Week 12