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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Metformin |
|
| 2 | Experimental | Oral Contraceptive Pills |
|
| 3 | Active Comparator | lifestyle modification program |
|
| 4 | Placebo Comparator | placebo to active metformin arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 425mg. capsules, 2 capsules BID x 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Free Androgen Index (FAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Hoeger, MD | University of Rochester | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Randomized to Metformin 1700mg daily for 24 weeks |
| FG001 | Oral Contraceptive | Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance |
| FG002 | Lifestyle Counseling | lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly |
| FG003 | Placebo to Metformin | randomized to placebo pill identical to active metformin arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Randomized to Metformin 1700mg daily for 24 weeks |
| BG001 | Oral Contraceptive | Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis was a description of number of recruited subjects. | Posted | Number | participants | 24 week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Randomized to Metformin 1700mg daily for 24 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen M Hoeger MD MPH | University of Rochester | 5852757891 | Kathy_hoeger@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C534342 | drospirenone and ethinyl estradiol combination |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Oral Contraceptive Pills (Yasmin) |
| Drug |
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks |
|
|
| Lifestyle Modification | Behavioral | weekly classes x 24 weeks for training in diet, exercise and behavior modification skills |
|
| placebo | Drug | placebo to the active metformin arm. 2 capsules BID x 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.
| baseline and 24 weeks |
| Change in SHBG | Measurement of SHBG by treatment group pre and post intervention | baseline and 24 weeks |
| 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 |
| Change in Fasting Glucose | Change in fasting glucose concentration by treatment group pre to post intervention | baseline and 24 weeks |
| BG002 | Lifestyle Counseling | lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly |
| BG003 | Placebo to Metformin | randomized to placebo pill identical to active metformin arm |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Lifestyle Counseling | lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly |
| OG003 | Placebo to Metformin | randomized to placebo pill identical to active metformin arm |
|
|
| 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 | Analysis per protocol | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 24 weeks |
|
|
|
|
| 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. | analysis per protocol | Posted | Mean | Standard Deviation | total T/SHBG | baseline and 24 weeks |
|
|
|
| Secondary | Change in SHBG | Measurement of SHBG by treatment group pre and post intervention | Posted | Mean | Standard Deviation | ratio | baseline and 24 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | baseline and 24 weeks |
|
|
|
| Secondary | Change in Fasting Glucose | Change in fasting glucose concentration by treatment group pre to post intervention | Posted | Mean | Standard Deviation | mg/dL | baseline and 24 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Oral Contraceptive | Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance | 0 | 11 | 0 | 11 |
| EG002 | Lifestyle Counseling | lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly | 0 | 11 | 0 | 11 |
| EG003 | Placebo to Metformin | randomized to placebo pill identical to active metformin arm | 0 | 10 | 0 | 10 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |