Status:
COMPLETED
PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome, Phase 2
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18+ years
Brief Summary
Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, man...
Detailed Description
Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, man...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be included in this study, primary twins must:
- Be a premenopausal female twin over the age 18 (this will be asked during recruitment).
- Have a living female co-twin (this will be asked during recruitment).
- Have a history of probable PCOS defined by having one or more of the following criteria as self-reported in the Phase 1 PCOS survey. These traits will be confirmed during medical evaluation:
- History of chronically irregular menstrual cycles
- History of hirsutism
- History of hair loss
- Cysts in ovaries
- Body-mass index greater than 25
- Acne
- Be able and willing to give informed consent.
- Agree to undergo a medical evaluation for PCOS.
- To be included in this study, co-twins must:
- Be a premenopausal female twin over the age of 18 (this will be asked during recruitment).
- Be able and willing to give informed consent.
- Agree to undergo a medical evaluation for PCOS.
- EXCLUSION CRITERIA:
- Women will be excluded from the study if they are pregnant or have given birth within the past six months.
- Women will also be excluded if they are currently menopausal or past menopause.
- Women with any condition that, in the opinion of the investigators, could affect the validity of the study results will be excluded from participating.
- Subjects will not be excluded based on race, ethnicity or religion.
Exclusion
Key Trial Info
Start Date :
February 27 2007
Trial Type :
OBSERVATIONAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00444288
Start Date
February 27 2007
End Date
March 1 2010
Last Update
July 2 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710