Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Overview[ - collapse ][ - ]

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)
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Drug: Oral Contraceptive Pills (Yasmin)
Behavioral: Lifestyle Modification
Drug: placebo
PhasePhase 3
SponsorUniversity of Rochester
Responsible PartyUniversity of Rochester
ClinicalTrials.gov IdentifierNCT00714233
First ReceivedJuly 8, 2008
Last UpdatedAugust 12, 2011
Last verifiedMay 2011

Tracking Information[ + expand ][ + ]

First Received DateJuly 8, 2008
Last Updated DateAugust 12, 2011
Start DateAugust 2002
Estimated Primary Completion DateDecember 2007
Current Primary Outcome MeasuresMeasure 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
Current 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

Descriptive Information[ + expand ][ + ]

Brief TitleTreatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Official TitleTreatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
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)
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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Metformin 425mg. capsules, 2 capsules BID x 24 weeks
Drug: Oral Contraceptive Pills (Yasmin)
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
Other Names:
Yasmin oral COntraceptive tabsBehavioral: 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.
Other Names:
pharmacy matched placebo capsules
Study Arm (s)
  • Experimental: 1
    Metformin
  • Experimental: 2
    Oral Contraceptive Pills
  • Active Comparator: 3
    lifestyle modification program
  • Placebo Comparator: 4
    placebo to active metformin arm

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment43
Estimated Completion DateDecember 2007
Estimated Primary Completion DateApril 2004
Eligibility 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
GenderFemale
Ages12 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00714233
Other Study ID NumbersRSRB # 09354
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Rochester
Study SponsorUniversity of Rochester
CollaboratorsNot Provided
Investigators Principal Investigator: Kathleen M Hoeger, MD University of Rochester
Verification DateMay 2011