Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Stopped early · Phase 4
Conditions studied: PCOS
In brief
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
Key facts
- Study ID
- NCT00703092
- Run by
- Virginia Commonwealth University
- People needed
- 2
- Starts
- 2008-02-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2017-10-09
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45
- Less than or equal to 8 periods annually
- elevated serum free testosterone concentrations
- normal thyroid function tests and serum prolactin
- exclusion of late-onset adrenal hyperplasia
- 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
You may not qualify if…
- Diabetes mellitus
- Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease
- high blood pressure
- current or recent(within 2 months 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
- ingestion of any investigational drugs within 4 weeks prior to study onset
- pregnancy or lactation(less than or equal to 6 weeks postpartum)
Where it is running
- VCU General Clinical Research Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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