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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

Must not have

History of known or suspected ischemic heart disease or cerebrovascular disease

Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL or cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after each intervention

Awards & highlights

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PCOS with signs of high male hormones and irregular periods.

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I am a woman aged 40-49 with PCOS.

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I am committed to using non-hormonal birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart or brain blood flow problems.

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My hormone levels indicate I am in perimenopause.

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I am not taking anticonvulsants, rifampicin, or rifabutin.

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I am a woman diagnosed with PCOS and not considered a child.

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I have a history of high blood pressure.

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I have had a stroke in the past.

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I understand what the study involves and why it's being done.

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I have a history of breast, ovarian, or endometrial cancer.

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I have had blood clots in my veins before.

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I have a history of severe liver disease or liver cancer.

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I have a history of congenital adrenal hyperplasia or my 17-OHP levels are above 200 ng/dL.

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I have diabetes with a fasting glucose of 126 mg/dL or higher, or an A1c of 6.5% or more.

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I have a history of heart failure.

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I have untreated high cholesterol.

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I have a history of serious heart valve problems.

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A close family member has a history of blood clotting disorders.

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I have a serious lung condition.

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I am postmenopausal, with no periods for the last year and high FSH levels.

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I have a history of blood clotting disorders.

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I have had my uterus and/or both ovaries removed.

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I have had Cushing's syndrome or adrenal insufficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after each intervention.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score

Secondary study objectives

Glucose

Blood pressure

Body mass index

+15 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 24Eligibility criteria met