Status:
TERMINATED
Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Indiana University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect o...
Detailed Description
The investigator hypothesizes that in women with PCOS, HCG administration will stimulate an exaggerated ovarian androgen response, dairy cream ingestion will stimulate white blood cells to generate an...
Eligibility Criteria
Inclusion
- General
- Acceptable health based on interview, medical history, physical examination, and lab tests
- Ability to comply with the requirements of the study
- Ability and willingness to provide signed, witnessed informed consent
- Inclusion Criteria for PCOS:
- Between the ages of 18-40 years
- Body mass index between 18 and 25, or between 30 and 40
- Less than or equal to 8 periods annually
- An elevated serum androgen level or skin manifestations of androgen excess
- Normal thyroid function tests and normal prolactin level
- Exclusion of late-onset adrenal hyperplasia
- Inclusion Criteria for Ovulatory Controls:
- Between the ages of 18-40 years
- Body mass index between 18 and 25, or between 30 and 40
- Normal regular monthly periods
- No clinical evidence of androgen excess
- No evidence of polycystic ovaries on ultrasound
Exclusion
- Diabetes mellitus
- Clinically significant pulmonary, cardiac ,renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
- High blood pressure
- Current or recent (within 6 weeks prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, thiazolidinediones, glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone, flutamide, etc)
- Documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
- Tobacco smoking if salsalate or PCE will be administered
- Ingestion of any investigational drugs within 4 weeks prior to study onset
- Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01489319
Start Date
February 1 2012
End Date
June 1 2015
Last Update
February 10 2017
Active Locations (1)
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1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202