Treatment of Adolescent Polycystic Ovary Syndrome (PCOS) - Full Text View

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00714233

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 elevated insulin levels
reduce androgen hormone levels
restore menstrual cycles and ovulation, 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 III

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Further study details as provided by University of Rochester:

Primary Outcome Measures:

recruit adolescent girls with PCOS into a 24 week pilot, randomized clinical trial with four arms- metformin, placebo, oral contraceptives or lifestyle modification [ Time Frame: 24 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the effectiveness of the lifestyle management program in producing sustained weight reduction in the overweight adolescent with PCOS [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Compare lifestyle management, metformin and placebo with respect to changes in insulin resistance, rates of ovulation and changes intestosterone, sex hormone binding globulin (SHBG), ovarian volume, body composition and lipids [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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
1: Experimental Metformin	Drug: Metformin Metformin 425mg. capsules, 2 capsules BID x 24 weeks
2: Experimental Oral Contraceptive Pills	Drug: Oral Contraceptive Pills (Yasmin) Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
3: Active Comparator lifestyle modification program	Behavioral: Lifestyle Modification weekly classes x 24 weeks for training in diet, exercise and behavior modification skills
4: Placebo Comparator placebo to active metformin arm	Drug: placebo placebo to the active metformin arm. 2 capsules BID x 24 weeks.

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
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

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:	University of Rochester Medical Center ( Kathleen M. Hoeger, MD )
Study ID Numbers:	RSRB # 09354, GCRC # 854
Study First Received:	July 8, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00714233
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Rochester:

Polycystic Ovary Syndrome
Overweight Adolescent Girls
Irregular Menstrual Cycles

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Metformin
Polycystic Ovary Syndrome
Drospirenone
Endocrine System Diseases

Overweight
Endocrinopathy
Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Hypoglycemic Agents
Pathologic Processes
Disease
Aldosterone Antagonists
Hormone Antagonists

Syndrome
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009