Clinical trial NCT00714233: Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Official title: Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Overweight Adolescent Girls
Irregular Menstrual Cycles
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 43
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

1. reduce fasting glucose levels
2. reduce androgen hormone levels
3. improve sex steroid binding, and
4. improve lipids (fatty substances in the blood)

Detailed description: Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.

Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Eligibility criteria: Inclusion Criteria:

* Menstrual irregularity defined as cycle length \> 45 days
* Overweight as BMI \> 25
* Clinical evidence of hirsuitism or acne
* Testosterone \> 50ng/dL

Exclusion Criteria:

* History of diabetes mellitus
* History of Cushing's disease
* History of hyperprolactinemia
* Untreated hypo or hyperthyroidism
* History of adrenal hyperplasia
* Significant renal impairment
* Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
* Exercise \> 10 hours per week

Primary outcomes:
measure: Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
timeFrame: 24 week
Secondary outcomes:
measure: Weight Loss in Lifestyle Intervention Group
timeFrame: baseline and 24 weeks
measure: Change in Free Androgen Index (FAI)
timeFrame: baseline and 24 weeks
measure: Change in SHBG
timeFrame: baseline and 24 weeks
measure: Triglyceride Concentration by Treatment Group
timeFrame: baseline and 24 weeks
measure: Change in Fasting Glucose
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Kathleen M Hoeger, MD
role: PRINCIPAL_INVESTIGATOR
References: