N/A
N=67
Metabolic Syndrome in PCOS: Precursors and Interventions
Polycystic Ovary Syndrome · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00442689 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Change in Low-density Lipoprotein (LDL) Levels Over the Study Period — -6; -9; -7 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- flutamide (Drug); ethinyl estradiol 35 mcg and drospirenone 3 mg (Drug); placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Low-density Lipoprotein (LDL) Levels Over the Study Period |
-6; -9; -7 | — |
| PRIMARY Change in High-density Lipoprotein (HDL) Levels During Study Period |
6; -5; -2 | — |
| PRIMARY Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI |
-0.1; -0.1; 0.1 | — |
| PRIMARY Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period |
0.4; -1.9; -1.9 | — |
| PRIMARY Change in Disposition Index |
1653; 194; -184 | — |
| PRIMARY Change in Resting Energy Expenditure (REE) Over the Study Period |
7; -79; -88 | — |
| PRIMARY Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period |
-0.5; -1.6; 1.1 | — |
Summary
The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.
Eligibility Criteria
Inclusion Criteria
- 6 periods or fewer per year
- Overweight
- All ethnicities
Exclusion Criteria
- Diabetes
- Heart Disease
- Chronic illness
- Regular Smokers
- Current use of Birth Control Pills, Patch, Ring, Depo
Data sourced from ClinicalTrials.gov (NCT00442689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.