Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

April 29, 2015 updated by: Kathleen M. Hoeger, MD, University of Rochester

Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Metformin
Drug: Metformin
Metformin 425mg. capsules, 2 capsules BID x 24 weeks
EXPERIMENTAL: 2
Oral Contraceptive Pills
Drug: Oral Contraceptive Pills (Yasmin)
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
Other Names:
  • Yasmin oral COntraceptive tabs
ACTIVE_COMPARATOR: 3
lifestyle modification program
Behavioral: Lifestyle Modification
weekly classes x 24 weeks for training in diet, exercise and behavior modification skills
PLACEBO_COMPARATOR: 4
placebo to active metformin arm
Drug: placebo
placebo to the active metformin arm. 2 capsules BID x 24 weeks.
Other Names:
  • pharmacy matched placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
Time Frame: 24 week
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
24 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss in Lifestyle Intervention Group
Time Frame: baseline and 24 weeks
In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI
baseline and 24 weeks
Change in Free Androgen Index (FAI)
Time Frame: baseline and 24 weeks
Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.
baseline and 24 weeks
Change in SHBG
Time Frame: baseline and 24 weeks
Measurement of SHBG by treatment group pre and post intervention
baseline and 24 weeks
Triglyceride Concentration by Treatment Group
Time Frame: baseline and 24 weeks
Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo
baseline and 24 weeks
Change in Fasting Glucose
Time Frame: baseline and 24 weeks
Change in fasting glucose concentration by treatment group pre to post intervention
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Kathleen M Hoeger, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (ACTUAL)

April 1, 2004

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB # 09354

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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