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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2010-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

Group Type EXPERIMENTAL

Lipitor

Intervention Type DRUG

40mg caplets per day for six weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 placebo caplet per day for six weeks.

Interventions

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Lipitor

40mg caplets per day for six weeks

Intervention Type DRUG

Placebo

1 placebo caplet per day for six weeks.

Intervention Type DRUG

Other Intervention Names

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Atorvastatin Sugar Pill

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No