Status:
COMPLETED
Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
Brief Summary
Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by elevated levels of testoster...
Detailed Description
BACKGROUND Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by hyperandrogenism,...
Eligibility Criteria
Inclusion
- Probands who meet the following criteria will be enrolled:
- Menses \< 6 per year without confounding meds Not taking confounding medications at the time of hormone analysis, willing to be off confounding medications for required washout period, or able to provide documentation of hyperandrogenemia (without hyperprolactinemia or evidence of non-classical adrenal hyperplasia) with past laboratory tests during a time when not taking confounding medications Total Testosterone \>58 ng/dl or bioavailable testosterone \>15 ng/dl Prolactin \<25 ng/ml Baseline 17-OHP \<3 ng/ml (and stimulated 17-OHP \<10 ng/ml if subject is studied on-site)
- Control women who meet the following criteria will be enrolled:
- History of completely regular menstrual cycles. No history of hirsutism or alopecia. Control women will have a blood sample obtained 3-6 months after they have stopped lactating and resumed regular menses to ensure that they have normal T, uT and DHEAS levels.
- Any pregnant woman who develops gestational diabetes will be excluded from the analysis.
- To exclude disorders associated with insulin resistance, control subjects will have no personal history of hypertension or hypertriglyceridemia and no first-degree relative with Type 2 DM
- Exclusion Criteria:
- history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00364949
Start Date
January 1 2003
End Date
July 1 2012
Last Update
April 10 2013
Active Locations (1)
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1
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611