Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151411
• Other study ID #: 2003-172
• Secondary ID: HD-02-012
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: March 19, 2018
• Start date: October 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
• Placebo
Placebo

Behavioral:
• Lifestyle Intervention
A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Testosterone After 6 Months of Treatment		baseline and 6 months
Secondary	Ovulation Rate	Count of ovulations per subject during the treatment period.	6 months
Secondary	Change in Insulin Sensitivity Index After 6 Months of Treatment		baseline and 6 months

External Links

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