Status:
COMPLETED
Comparing the Effects of Oral Contraceptive Pills Versus Metformin
Lead Sponsor:
Anuja Dokras
Collaborating Sponsors:
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
Conditions:
PCOS
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in overweight/obese women with Pol...
Detailed Description
The intervention will consist of randomizing subjects to one of three arms. Subjects will either be assigned to OCP + Placebo, Metformin + Placebo or OCP + Metformin. Metformin will be initiated in a ...
Eligibility Criteria
Inclusion
- Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.
- Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on:
- androgen excess (defined as an elevated serum T level or hirsutism, based on a Ferriman Gallwey score \> 8 (note: \> 2 for women of Asian descent)
- AND either:
- history of chronic anovulation (8 or fewer periods per year)
- AND/OR
- polycystic ovaries.
- BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.
- In good general health.
- Willing to avoid pregnancy for the duration of the study.
Exclusion
- Current pregnancy or desire of pregnancy during course of study
- Currently breastfeeding
- Known 21 hydroxylase deficiency
- Untreated thyroid disease (TSH \<0.45 mlU/mL and \> 4.5 mlU/mL)
- Untreated hyperprolactinemia (2 Levels\>30 ng/ml at least one week apart)
- Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose \>126mg/dL on two occasions, poorly controlled diabetes (HgbA1C\>6.5%), currently receiving anti-diabetic agents, or currently receiving metformin for treatment of diabetes
- Liver disease (AST/ALT\>2 times normal or a total bilirubin \>2.5 mg/dL)
- Renal disease (BUN\>30 mg/dL or serum creatinine \>1.4 mg/dL)
- Anemia (hemoglobin \<10 mg/dL)
- History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident
- Current history of alcohol abuse (\>14drinks/week)
- Poorly controlled hypertension defined as average systolic blood pressure \>= 150 mm Hg or average diastolic \>=100 mm Hg obtained on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure \>=140 mm Hg or average diastolic \>=90 mm Hg
- Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma
- TG\>200mg/dl
- Use of lipid lowering or weight loss agents (subjects may wash out from weight loss agents)
- Current use of oral contraceptives, depo progestin, or hormonal implants
- Participation in any study of an investigational drug or device or biological agent within 30 days
- Suspected adrenal or ovarian tumor secreting androgens
- Suspected Cushing's syndrome
- Bariatric surgery procedure in the recent past (\<12 months)
- Absolute contraindications to the use of hormonal contraceptives or metformin,
- 23\. Subjects who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03229057
Start Date
January 15 2018
End Date
July 15 2024
Last Update
November 5 2025
Active Locations (2)
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1
Penn State/ Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104