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Combined Oral Contraceptive

Oral Contraceptives for Premenstrual Dysphoric Disorder

Phase 2
Recruiting
Led By Benicio N Frey, MD, MSc,PhD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
16-45 years of age
No contraindication to use oral contraceptives
Must not have
Current unstable medical conditions
Oophorectomy or hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is evaluating the use of combined oral contraceptives as a treatment for premenstrual dysphoric disorder comorbid with bipolar disorder.

Who is the study for?
This trial is for individuals aged 16-45 with bipolar disorder who are stable and have severe premenstrual symptoms (PMDD). They must be able to consent, not smoke if over 35, have regular menstrual cycles, and no history of hormone-sensitive cancers or clotting disorders. Those pregnant, breastfeeding, or with recent hormone treatments cannot join.Check my eligibility
What is being tested?
The study tests whether oral contraceptives can help manage severe premenstrual symptoms in those also dealing with bipolar disorder. Participants will randomly receive either the contraceptive Yaz or a placebo for three months while their health is monitored.See study design
What are the potential side effects?
Potential side effects from the oral contraceptive may include nausea, headaches, mood changes, breast tenderness, and spotting between periods. The risk of blood clots may also be slightly increased.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 45 years old.
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I can safely use oral contraceptives.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unstable health conditions.
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I have had my ovaries or uterus removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility outcome: duration of assessment process
Feasibility outcome: estimated treatment effect
Feasibility outcome: recruitment capacity
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)Experimental Treatment1 Intervention
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Continuous treatment with placebo for 12 weeks

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Bipolar Disorder include mood stabilizers, antipsychotics, and anticonvulsants. Lithium works by modulating neurotransmitter activity and stabilizing mood swings, while valproate increases levels of gamma-aminobutyric acid (GABA) to calm neural activity. Antipsychotics like risperidone and quetiapine target dopamine and serotonin receptors to manage manic and psychotic symptoms. Lamotrigine, an anticonvulsant, stabilizes mood by inhibiting glutamate release and blocking sodium channels. Additionally, hormone regulation through combined oral contraceptives may help manage mood fluctuations by stabilizing estrogen and progesterone levels. These treatments are crucial for Bipolar Disorder patients as they help maintain mood stability, reduce the frequency of mood episodes, and improve overall quality of life.
A systematic review of the evidence on the treatment of rapid cycling bipolar disorder.

Find a Location

Who is running the clinical trial?

Hamilton Academic Health Sciences OrganizationOTHER
20 Previous Clinical Trials
4,806 Total Patients Enrolled
St. Joseph's Healthcare HamiltonLead Sponsor
197 Previous Clinical Trials
26,389 Total Patients Enrolled
4 Trials studying Bipolar Disorder
374 Patients Enrolled for Bipolar Disorder
McMaster UniversityOTHER
896 Previous Clinical Trials
2,610,170 Total Patients Enrolled
2 Trials studying Bipolar Disorder
258 Patients Enrolled for Bipolar Disorder

Media Library

Yaz (Combined Oral Contraceptive) Clinical Trial Eligibility Overview. Trial Name: NCT05098574 — Phase 2
Bipolar Disorder Research Study Groups: Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol), Placebo
Bipolar Disorder Clinical Trial 2023: Yaz Highlights & Side Effects. Trial Name: NCT05098574 — Phase 2
Yaz (Combined Oral Contraceptive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098574 — Phase 2
~23 spots leftby Jul 2025