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Biguanides

Metformin vs. Birth Control Pills for Polycystic Ovary Syndrome (SHK002 Trial)

Phase < 1
Recruiting
Led By Chris McCartney, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is considered to have PCOS if she has current or verifiable history of: clinical and/or biochemical evidence of hyperandrogenism plus oligomenorrhea or irregular menstruation
Women with PCOS aged 40-49 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after each intervention
Awards & highlights

SHK002 Trial Summary

This trial will compare metformin to oral combined hormonal contraceptives in treating Polycystic Ovary Syndrome in women of later reproductive age, using the Polycystic Ovary Syndrome Questionnaire score as a proxy for patient satisfaction.

Who is the study for?
Women aged 40-49 with PCOS, having irregular or infrequent menstrual cycles and signs of high male hormones. They should not be at risk for pregnancy, have a history of severe liver disease, heart problems, stroke, blood clots, certain cancers or uncontrolled cholesterol levels. Participants must avoid medications affecting the reproductive system before the trial.Check my eligibility
What is being tested?
The study is testing whether metformin or birth control pills (oral contraceptives) are more satisfying for treating symptoms of PCOS in women nearing menopause. Satisfaction will be measured using a questionnaire designed to assess patient contentment with their treatment.See study design
What are the potential side effects?
Metformin may cause digestive issues like diarrhea and nausea; oral contraceptives can increase the risk of blood clots, headaches and may affect mood and weight. Each woman's experience with side effects could vary.

SHK002 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PCOS with signs of high male hormones and irregular periods.
Select...
I am a woman aged 40-49 with PCOS.
Select...
I am committed to using non-hormonal birth control during the study.

SHK002 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after each intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after each intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score
Secondary outcome measures
Glucose
Blood pressure
Body mass index
+15 more

SHK002 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Metformin then oral combined hormonal contraceptivesExperimental Treatment2 Interventions
Subjects will take metformin 2000 mg/day for the first 6 months, followed by 6 months of oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg.
Group II: Oral combined hormonal contraceptives then metforminActive Control2 Interventions
Subjects will take oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg for the first 6 months, followed by 6 months of metformin 2000 mg/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
759 Previous Clinical Trials
1,245,498 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,116 Patients Enrolled for Polycystic Ovary Syndrome
Chris McCartney, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
204 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
204 Patients Enrolled for Polycystic Ovary Syndrome
Su H Kim, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
144 Patients Enrolled for Polycystic Ovary Syndrome
~43 spots leftby Apr 2027
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