Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
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Purpose
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome |
Drug: Metformin Drug: Oral Contraceptive Pill Behavioral: Lifestyle Management Program Behavioral: Quality of Life Questionnaire Procedure: Oral Glucose Tolerance Test Procedure: Blood work Procedure: Abdominal Ultra Sound Procedure: Dual-energy x-ray absorptiometry (DEXA scan) Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS) |
- Reduction in Abdominal Fat as Measured by Waist Circumference. [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
- Change in Weight Post Minus Pre Intervention. [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]Body mass index change in adolescents enrolled in lifestyle intervention program
- Total Testosterone Change [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]Change in total testosterone post minus pre intervention
- Change in Sex Hormone Binding Globulin (SHBG) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]SHBG concentration post minus pre-intervention
| Enrollment: | 36 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
metformin
|
Drug: Metformin
Metformin 500 mg. tabs 2 tabs BID for duration of study
Other Names:
Drug: Oral Contraceptive Pill
Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study Other Names:
Behavioral: Lifestyle Management Program
Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise & behavior modification skills on a regular weekly basis over the 24 week study
Behavioral: Quality of Life Questionnaire
Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion
Procedure: Oral Glucose Tolerance Test
Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.
Procedure: Abdominal Ultra Sound
transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion
|
|
Placebo Comparator: 0
placebo
|
Drug: Oral Contraceptive Pill
Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study Other Names:
Behavioral: Lifestyle Management Program
Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise & behavior modification skills on a regular weekly basis over the 24 week study
Behavioral: Quality of Life Questionnaire
Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion
Procedure: Oral Glucose Tolerance Test
Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.
Procedure: Abdominal Ultra Sound
transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion
Drug: placebo
placebo capsules, two capsules BID
Other Names:
|
Detailed Description:
Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS.
The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle.
Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight > 300 lbs.
Contacts and Locations| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Kathleen Hoeger, MD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Kathleen Hoeger, MD, University of Rochester Medical Center |
| ClinicalTrials.gov Identifier: | NCT00283816 History of Changes |
| Other Study ID Numbers: | RSRB-00012501, GCRC#1083 |
| Study First Received: | January 27, 2006 |
| Results First Received: | April 8, 2011 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Rochester:
|
Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Contraceptive Agents |
Contraceptives, Oral Contraceptives, Oral, Combined Metformin Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 19, 2013