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Completed

NCT Number: NCT05098574

Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

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.

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Key information

Conditions

Premenstrual Dysphoric Disorder Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16-45 years of age
  • 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

  • Smoking and over the age of 35
  • 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.

Treatment and study plan

Yaz

Drug

Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks

Other names: 3mg drospirenone/ 0.02mg ethinyl estradiol

Placebo

Drug

Appearance, packaging, and labeling of placebo will be matched to their active counterpart.

Primary outcomes

  1. Feasibility outcome: treatment compliance

    Time frame: 12 weeks

    Treatment compliance - assessed via number and percentage of treatment pills taken

  2. Feasibility outcome: retention rates

    Time frame: 12 weeks

    Retention rates - number and percentage of people who remain in the study once randomized

  3. Feasibility outcome: recruitment rate (monthly)

    Time frame: 2 years

    Recruitment rate (monthly) - number of participants per month

  4. Feasibility outcome: recruitment capacity

    Time frame: 2 years

    Recruitment capacity - total number of participants randomized and enrolled

  5. Feasibility outcome: screening rates (monthly)

    Time frame: 2 years

    Screening rates (monthly) - number screened; number enrolled as a percentage of number screened

  6. Feasibility outcome: duration of assessment process

    Time frame: Screening

    Duration of assessment process - mean in hours from start to finish for each visit

  7. Feasibility outcome: duration of assessment process

    Time frame: Baseline

    Duration of assessment process - mean in hours from start to finish for each visit

  8. Feasibility outcome: duration of assessment process

    Time frame: Week 4

    Duration of assessment process - mean in hours from start to finish for each visit

  9. Feasibility outcome: duration of assessment process

    Time frame: Week 8

    Duration of assessment process - mean in hours from start to finish for each visit

  10. Feasibility outcome: duration of assessment process

    Time frame: Week 12

    Duration of assessment process - mean in hours from start to finish for each visit

  11. Feasibility outcome: safety of use of oral contraceptives in this population

    Time frame: Week 4

    Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)

  12. Feasibility outcome: safety of use of oral contraceptives in this population

    Time frame: Week 8

    Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)

  13. Feasibility outcome: safety of use of oral contraceptives in this population

    Time frame: Week 12

    Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)

  14. Feasibility outcome: tolerability

    Time frame: Week 4

    Tolerability - assessed as percentage dropped out after randomization due to adverse events

  15. Feasibility outcome: tolerability

    Time frame: Week 8

    Tolerability - assessed as percentage dropped out after randomization due to adverse events

  16. Feasibility outcome: tolerability

    Time frame: Week 12

    Tolerability - assessed as percentage dropped out after randomization due to adverse events

  17. Feasibility outcome: response rates

    Time frame: Week 12

    Response rates - response will be defined as 50% decrease from baseline symptom change from late luteal to follicular phase; remission will be defined as number and percentage of responders who no longer need DSM-5 criteria for PMDD

  18. Feasibility outcome: estimated treatment effect

    Time frame: Week 12

    Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase

  19. Feasibility outcome: variance of the treatment effect

    Time frame: Week 12

    Variance of the treatment effect - standard deviation of above measure.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Hamilton Academic Health Sciences Organization
  • McMaster University

Registry information

Official study title

A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2021
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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