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Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

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ClinicalTrials.gov Identifier: NCT00283816
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : July 13, 2011
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester

Tracking Information
First Submitted Date  ICMJE January 27, 2006
First Posted Date  ICMJE January 30, 2006
Results First Submitted Date  ICMJE April 8, 2011
Results First Posted Date  ICMJE July 13, 2011
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
Reduction in Abdominal Fat as Measured by Waist Circumference. [ Time Frame: baseline and 24 weeks ]
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
24 week trial to compare effect of metformin to placebo, in combination with oral contraceptives with respect to change in metabolic parameters of increased cardiovascular risk and insulin resistance.
Change History Complete list of historical versions of study NCT00283816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • Change in Weight Post Minus Pre Intervention. [ Time Frame: baseline and 24 weeks ]
    Body mass index change in adolescents enrolled in lifestyle intervention program
  • Total Testosterone Change [ Time Frame: baseline and 24 weeks ]
    Change in total testosterone post minus pre intervention
  • Change in Sex Hormone Binding Globulin (SHBG) [ Time Frame: baseline and 24 weeks ]
    SHBG concentration post minus pre-intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
Assess the effectiveness & impact of a lifestyle management program in combination with oral contraceptives +/- metformin in producing weigh reduction and improvement in fitness capacity in obese adolescents with PCOS.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Official Title  ICMJE Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Metformin
    Metformin 500 mg. tabs 2 tabs BID for duration of study
    Other Names:
    • Metformin Hydrochloride Tablets, 500 mg.
    • manufacturer: Mylan Pharmaceuticals, Morgantown, WV
  • Drug: Oral Contraceptive Pill

    Yasmin, drospirenone and ethinyl estradiol 28 tablets

    1 tab daily for duration of study

    Other Names:
    • Yasmin 28 tablets
    • Manufacturer: Berlex, Montville, NJ 07045
  • 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

  • Procedure: Blood work
    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

  • Procedure: Dual-energy x-ray absorptiometry (DEXA scan)
    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:
    • placebo formulation: 240 mg. lactose powder USP
    • in size 3 capsules from Capsugel
Study Arms  ICMJE
  • Active Comparator: 1
    metformin
    Interventions:
    • 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)
  • Placebo Comparator: 0
    placebo
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2008)
36
Original Enrollment  ICMJE
 (submitted: January 27, 2006)
40
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283816
Other Study ID Numbers  ICMJE RSRB-00012501
GCRC#1083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathleen M. Hoeger, MD, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Hoeger, MD University of Rochester
PRS Account University of Rochester
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP