Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:	Kathleen M Hoeger, MD	University of Rochester

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	July 14, 2008
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