Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Hamilton Academic Health Sciences Organization; McMaster University
• Treatments: Drospirenone; Estradiol; Ethinyl Estradiol

Criteria

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.