Clinical trial NCT00151411: Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Official title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome (PCOS)
Anovulation
Elevated Testosterone
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-09-09
Enrollment: 114
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
* Diabetes, liver, heart, kidney or uncorrected thyroid disease

Primary outcomes:
measure: Change in Testosterone After 6 Months of Treatment
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Ovulation Rate
timeFrame: 6 months
measure: Change in Insulin Sensitivity Index After 6 Months of Treatment
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048.
citation: Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30.