Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT00714233
First received: July 8, 2008
Last updated: April 29, 2015
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
 Drug: Metformin
Drug: Oral Contraceptive Pills (Yasmin)
Behavioral: Lifestyle Modification
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Weight Loss in Lifestyle Intervention Group [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI

  • Change in Free Androgen Index (FAI) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in SHBG [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    Measurement of SHBG by treatment group pre and post intervention

  • Triglyceride Concentration by Treatment Group [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo

  • Change in Fasting Glucose [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    Change in fasting glucose concentration by treatment group pre to post intervention
Enrollment: 43
Study Start Date: August 2002
Study Completion Date: December 2007
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714233

Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Kathleen M Hoeger, MD University of Rochester
  More Information

Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00714233     History of Changes
Other Study ID Numbers: RSRB # 09354 
Study First Received: July 8, 2008
Results First Received: April 8, 2011
Last Updated: April 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Polycystic Ovary Syndrome
Overweight Adolescent Girls
Irregular Menstrual Cycles

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Metformin
Contraceptive Agents
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Contraceptives, Oral, Combined
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 26, 2016