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Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714233
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 16, 2011
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester

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)

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Oral Contraceptive Pills (Yasmin) Behavioral: Lifestyle Modification Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
Study Start Date : August 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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 Name: 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 Name: pharmacy matched placebo capsules

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Change in SHBG [ Time Frame: baseline and 24 weeks ]
    Measurement of SHBG by treatment group pre and post intervention

  4. 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

  5. Change in Fasting Glucose [ Time Frame: baseline and 24 weeks ]
    Change in fasting glucose concentration by treatment group pre to post intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714233

Sponsors and Collaborators
University of Rochester
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Principal Investigator: Kathleen M Hoeger, MD University of Rochester
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Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester Identifier: NCT00714233    
Other Study ID Numbers: RSRB # 09354
First Posted: July 14, 2008    Key Record Dates
Results First Posted: September 16, 2011
Last Update Posted: May 15, 2015
Last Verified: May 2011
Keywords provided by Kathleen M. Hoeger, MD, University of Rochester:
Polycystic Ovary Syndrome
Overweight Adolescent Girls
Irregular Menstrual Cycles
Additional relevant MeSH terms:
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Drospirenone and ethinyl estradiol combination
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female