A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol

Penn State Health

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Lipitor

Study type: Interventional

Funder types: Other

Identifiers

NCT00529542

19286

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

Full description

The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Women with PCOS

• 8 or fewer menstrual periods per year
• elevated serum total testosterone
• elevated LDL cholesterol

Exclusion Criteria:

• current pregnancy or breastfeeding
• current use of oral contraceptives, progestins
• insulin sensitizing medications
• thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Treatment:

Drug: Lipitor

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo