Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00714233

Enrollment

Registered

2008-07-14

Start date

2002-08-31

Completion date

2007-12-31

Last updated

2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, Overweight Adolescent Girls, Irregular Menstrual Cycles

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.

Interventions

DRUGMetformin

Metformin 425mg. capsules, 2 capsules BID x 24 weeks

DRUGOral Contraceptive Pills (Yasmin)

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

BEHAVIORALLifestyle Modification

weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	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

Measure	Time frame	Description
Weight Loss in Lifestyle Intervention Group	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)	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	baseline and 24 weeks	Measurement of SHBG by treatment group pre and post intervention
Triglyceride Concentration by Treatment Group	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	baseline and 24 weeks	Change in fasting glucose concentration by treatment group pre to post intervention

Participant flow

Participants by arm

Arm	Count
Metformin Randomized to Metformin 1700mg daily for 24 weeks	10
Oral Contraceptive Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance	11
Lifestyle Counseling lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly	11
Placebo to Metformin randomized to placebo pill identical to active metformin arm	10
Total	42

Baseline characteristics

Characteristic	Placebo to Metformin	Total	Metformin	Oral Contraceptive	Lifestyle Counseling
Age, Categorical <=18 years	10 Participants	42 Participants	10 Participants	11 Participants	11 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	15.4 years STANDARD_DEVIATION 1.7	15.6 years STANDARD_DEVIATION 1.4	16 years STANDARD_DEVIATION 1.7	15.4 years STANDARD_DEVIATION 1.4	15.4 years STANDARD_DEVIATION 1.2
Region of Enrollment United States	10 participants	42 participants	10 participants	11 participants	11 participants
Sex: Female, Male Female	10 Participants	42 Participants	10 Participants	11 Participants	11 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 10	0 / 11	0 / 11	0 / 10
serious Total, serious adverse events	0 / 10	0 / 11	0 / 11	0 / 10

Outcome results

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

Time frame: 24 week

Population: Analysis was a description of number of recruited subjects.

Arm	Measure	Value (NUMBER)
Metformin	Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	10 participants
Oral Contraceptive	Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	11 participants
Lifestyle Counseling	Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	11 participants
Placebo to Metformin	Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	10 participants

Secondary