Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

NCT05098574 | Completed Phase 2 DMC

• 1 other identifier: BDPMDD01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Dysphoric Disorder; Bipolar Disorder

Keywords

bipolar disorder; premenstrual dysphoric disorder

Outcome Measures

Primary Outcomes (19)

• Feasibility outcome: treatment compliance

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

  12 weeks

• Feasibility outcome: retention rates

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

  12 weeks

• Feasibility outcome: recruitment rate (monthly)

  Recruitment rate (monthly) - number of participants per month

  2 years

• Feasibility outcome: recruitment capacity

  Recruitment capacity - total number of participants randomized and enrolled

  2 years

• Feasibility outcome: screening rates (monthly)

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

  2 years

• Feasibility outcome: duration of assessment process

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

  Screening

• Feasibility outcome: duration of assessment process

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

  Baseline

• Feasibility outcome: duration of assessment process

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

  Week 4

• Feasibility outcome: duration of assessment process

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

  Week 8

• Feasibility outcome: duration of assessment process

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

  Week 12

• Feasibility outcome: safety of use of oral contraceptives in this population

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

  Week 4

• Feasibility outcome: safety of use of oral contraceptives in this population

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

  Week 8

• Feasibility outcome: safety of use of oral contraceptives in this population

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

  Week 12

• Feasibility outcome: tolerability

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

  Week 4

• Feasibility outcome: tolerability

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

  Week 8

• Feasibility outcome: tolerability

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

  Week 12

• Feasibility outcome: response rates

  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

  Week 12

• Feasibility outcome: estimated treatment effect

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

  Week 12

• Feasibility outcome: variance of the treatment effect

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

  Week 12

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Yaz

Placebo

PLACEBO COMPARATOR

Continuous treatment with placebo for 12 weeks

Drug: Placebo

Interventions

Yaz DRUG

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

Also known as: 3mg drospirenone/ 0.02mg ethinyl estradiol

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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Hamilton Academic Health Sciences Organization: collaborator
• McMaster University: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

Related Publications (1)

• 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.

  PMID: 37365881 DERIVED

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder; Bipolar Disorder

Interventions

drospirenone and ethinyl estradiol combination; drospirenone; Ethinyl Estradiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Benicio N Frey, MD, MSc,PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist/ Professor

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: October 28, 2021
• Study Start: February 3, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)