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Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

NCT05098574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-09-23

No results posted yet for this study

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

Interventions

DRUG

Yaz

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Hamilton Academic Health Sciences Organization

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Benicio N Frey, MD, MSc,PhD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098574 on ClinicalTrials.gov