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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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
Select...
I am between 16 and 45 years old.
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I can safely use oral contraceptives.

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

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
196 Previous Clinical Trials
25,484 Total Patients Enrolled
4 Trials studying Bipolar Disorder
374 Patients Enrolled for Bipolar Disorder
McMaster UniversityOTHER
884 Previous Clinical Trials
2,598,256 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Yaz's clinical trial history extensive?

"Currently, there are 17 ongoing studies involving the medication Yaz. Of these, 3 trials have reached Phase 3. Most of the research is being conducted from Savannah, Georgia; however, there are 28 total locations running trials for Yaz."

Answered by AI

Has the Yaz birth control method been cleared by the FDA?

"While there is some evidence to support Yaz's safety, it did not score higher because this is only a Phase 2 trial. This means that while there have been some studies conducted on its safety, none have been done on whether or not the medication is actually effective."

Answered by AI

How many people are allowed to sign up for this experiment?

"This particular clinical trial is not seeking new participants at this time. The study was originally posted on November 1st, 2021 and was last edited on October 18th, 20211. If you are looking for other studies, there are 1042 trials concerning manic disorder and 17 Yaz trials that are currently ongoing."

Answered by AI

Could I qualify to be a test subject for this experiment?

"Individuals with manic disorder that fall between the ages of 16 and 45 may be accepted into this clinical trial. There are only 60 spots available in total."

Answered by AI

What conditions is Yaz most often prescribed for?

"Yaz is an effective medication for treating acne vulgaris, the vasomotor system, and post-menarche."

Answered by AI

Are minors included in the patient population for this research?

"This clinical trial is only open to patients who are below 45 years old and have already celebrated their 16th birthday."

Answered by AI

Are there any available positions for volunteers in this trial?

"This particular trial, which was posted on November 1st 2021 and updated 18th October 2021, is not currently looking for candidates. Although, there are many other trials (1059 to be exact) that might have open positions."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
St Joseph's Healthcare Hamilton
Recent research and studies
clinicaltrials.govStudy
Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
Benicio Frey 2022. "Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098574.
All > Bipolar Disorder > Pmdd
~26 spots leftby Apr 2025
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