Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714233
• Other study ID #: RSRB # 09354
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2008
• Last updated: April 29, 2015
• Start date: August 2002
• Est. completion date: December 2007

Study information

• Verified date: May 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2007
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Metformin 425mg. capsules, 2 capsules BID x 24 weeks
• Oral Contraceptive Pills (Yasmin)
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

Behavioral:
• Lifestyle Modification
weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

Drug:
• placebo
placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	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	24 week	No
Secondary	Weight Loss in Lifestyle Intervention Group	In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI	baseline and 24 weeks	No
Secondary	Change in Free Androgen Index (FAI)	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.	baseline and 24 weeks	No
Secondary	Change in SHBG	Measurement of SHBG by treatment group pre and post intervention	baseline and 24 weeks	No
Secondary	Triglyceride Concentration by Treatment Group	Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo	baseline and 24 weeks	No
Secondary	Change in Fasting Glucose	Change in fasting glucose concentration by treatment group pre to post intervention	baseline and 24 weeks	No