Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 2

Conditions: Bipolar Disorder; Premenstrual Dysphoric Disorder

Treatments: Drug: Placebo; Drug: Yaz

Study type: Interventional

Funder types: Other

Identifiers

NCT05098574

BDPMDD01

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)

Experimental group

Description:

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

Treatment:

Drug: Yaz

Placebo

Placebo Comparator group

Description:

Continuous treatment with placebo for 12 weeks

Treatment:

Drug: Placebo