Status:
COMPLETED
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
19-40 years
Phase:
NA
Brief Summary
The primary objective is to determine if meals of different fat and fiber content affect postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our hypothesis is that ...
Detailed Description
The study participants are 15 women with PCOS between the ages of 19-40. All participants must be in good health, non-smokers, and not pregnant or lactating. For three days prior to both study visits,...
Eligibility Criteria
Inclusion
- Chronic oligo/anovulation - intermenstrual periods of ≥ 45 days or ≤ 8 menses per year.
- Hyperandrogenemia - elevated total testosterone or free androgen index (ratio of testosterone/SHBG x 100). To participate in the study, women must have total testosterone \>50 ng/dL or a free androgen index \>1.5
- In good general health
Exclusion
- Currently pregnant or lactating
- Use of confounding medications such as oral contraceptives or other hormonal medication, lipid lowering medications or insulin sensitizing agents such as metformin or the glitazones.
- Tobacco use
- Alcohol consumption of more than two drinks per day
- Unusual meal patterns (including no breakfast, breakfast before 6 am or breakfast after 10am.
- Untreated hyperprolactinaemia (Prolactin \>25ng/ml)
- Uncontrolled hypothyroidism
- History of blood clotting disorder
- Diagnosis of anemia at baseline visit
- Presence or history of diabetes mellitus
- Existence of an organic intra cranial lesion such as a pituitary tumor.
- Presence or history of coronary artery disease
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00455338
Start Date
May 1 2005
End Date
November 1 2006
Last Update
April 3 2007
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