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Trial record 32 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640224
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Silva Arslanian, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 18, 2008
First Posted Date  ICMJE March 21, 2008
Results First Submitted Date  ICMJE July 27, 2017
Results First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE March 2005
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Peripheral Insulin Sensitivity at Baseline and 6 Months. [ Time Frame: Baseline and 6 months ]
    Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
  • Hepatic Insulin Sensitivity at Baseline and 6 Months. [ Time Frame: Baseline and 6 months ]
    Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
  • Glucose Tolerance Status at Baseline and 6 Months. [ Time Frame: Baseline and 6 months ]
    Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism, insulin resistance, inflammation and bone turnover. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00640224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Total Fat Mass at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
  • Total Testosterone at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
  • Percent Body Fat at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DXA scans were done to measure the percentage of body fat.
  • Free Testosterone at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Free testosterone was measured by equilibrium dialysis.
  • SHBG at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
  • DHEAS at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
  • Delta Androstenedione at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
  • Delta DHEA at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta DHEA was measured by HPLC-tandem mass spectroscopy.
  • Delta 17-OHProg at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
  • Delta 17-OHPreg at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
  • Cholesterol at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
  • HDL at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
  • LDL at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
  • Triglycerides at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
  • Non-HDL Cholesterol at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
  • Adiponectin at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Adiponectin was measured by radioimmunoassay.
  • Leptin at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Leptin was measured by radioimmunoassay.
  • Hs-CRP at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
  • Morning Blood Pressure at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Morning blood pressure was measured with an automated sphygmomanometer.
  • Night Blood Pressure at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Night blood pressure was measured with an automated sphygmomanometer.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
To compare the changes within the PCOS group to normal developmental changes in overweight females without PCOS [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Official Title  ICMJE Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
Brief Summary The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).
Detailed Description

The purpose of this study is to:

1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: rosiglitazone
    4 mg daily for 6 months
    Other Name: Avandia
  • Drug: drospirenone/ethinyl estradiol
    1 tab (3mg/30mcg) daily for 6 months
    Other Name: Yasmin
Study Arms  ICMJE
  • Active Comparator: Rosiglitazone
    Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
    Intervention: Drug: rosiglitazone
  • Active Comparator: Drospirenone/ethinyl estradiol
    Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
    Intervention: Drug: drospirenone/ethinyl estradiol
  • No Intervention: Overweight/Obese without PCOS
    Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm.
  • No Intervention: Lean without PCOS
    Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm.
Publications * Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16.

*   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: January 27, 2016)
65
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2008)
75
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 10 - 20 years
  • Pubertal level of Tanner stage III-V and menarchal
  • BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

  • Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
  • Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
  • Established diagnosis of diabetes
  • Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
  • Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
  • Vitamin D deficiency (<10ng/mL)
  • Hyperkalemia (K>5.0 meq/L)
  • Positive pregnancy test (serum)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 20 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 NCT00640224
Other Study ID Numbers  ICMJE 0503013
2K24HD001357 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silva Arslanian, University of Pittsburgh
Study Sponsor  ICMJE Silva Arslanian
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Silva Arslanian, M.D. University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2017

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