Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 12 - 39 |
| Updated: | 4/17/2018 |
| Start Date: | October 2004 |
| End Date: | March 2008 |
The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
The purpose of this study is 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.
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.
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.
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.
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, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
- Diabetes, liver, heart, kidney or uncorrected thyroid disease
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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