Lifestyle Intervention and Metformin for Women With PCOS
Information source: Penn State University
Information obtained from ClinicalTrials.gov on May 11, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Metformin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Richard Legro, M.D., Principal Investigator, Affiliation: Penn State Milton S. Hershey Medical Center
Overall contact:
Patsy Rawa, B.S., Phone: 717-531-3692, Email: prawa@psu.edu
Summary
To determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.
Clinical Details
Official title:
The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: We hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia that single agent therapy.
Secondary outcome: We hypothesize that combination therapy will result in a greater improvement in ovulatory frequency and insulin sensitivity that single agent therapy.
Detailed description:
PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.
Eligibility
Minimum age: 12 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
- Elevated testosterone levels
- General good health
- Off of current medications which may confound response to study medications
Exclusion Criteria:
- Pregnancy
- Lactose Intolerance
- Medical Contraindications
- Elevated Prolactin, 17 OHP, or FSH blood tests
- Diabetes, liver, heart, kidney or uncorrected thyroid disease
Locations and Contacts
Patsy Rawa, B.S., Phone: 717-531-3692, Email: prawa@psu.edu
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Patsy Rawa, B.S., Phone: 717-531-3692, Email: prawa@psu.edu
Sandy Eyer, Phone: 717-531-1540, Email: seyer@psu.edu
Richard Legro, M.D., Principal Investigator
Additional Information
Click here for more information about this study
Starting date:
October 2004
Ending date: October 2007
Last updated: September 8, 2005
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