Pilot Study:Role of Dietary Fiber in PCOS Anovulation

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)