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Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00714233

First Posted: July 14, 2008

Last Update Posted: May 15, 2015

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.

Information provided by (Responsible Party):

Kathleen M. Hoeger, MD, University of Rochester

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:

reduce fasting glucose levels
reduce androgen hormone levels
improve sex steroid binding, and
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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Polycystic Ovary Syndrome

U.S. FDA Resources

Further study details as provided by Kathleen M. Hoeger, MD, 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 ]
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 ]
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 ]
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 ]
Measurement of SHBG by treatment group pre and post intervention
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
Change in Fasting Glucose [ Time Frame: baseline and 24 weeks ]
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

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

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

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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	July 8, 2008
First Posted:	July 14, 2008
Results First Submitted:	April 8, 2011
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:


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 Contraceptives, Oral, Combined Drospirenone and ethinyl estradiol combination Hypoglycemic Agents Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female

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