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Trial record 13 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Polycystic Ovary Syndrome
Interventions: Drug: rosiglitazone
Drug: drospirenone/ethinyl estradiol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overweight/obese patients with PCOS were recruited from the Children’s Hospital of Pittsburgh (CHP) PCOS center and the community through advertisements and flyers posted in the medical campus and in pediatricians’ offices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
9 did not meet diagnostic criteria, 3 were on psychiatric meds,1 was diagnosed with diabetes,1 had venous access issues, and 5 did not complete baseline evaluations. No participants were enrolled in the "Overweight/Obese without PCOS" or "Lean without PCOS" Arms/Groups.

Reporting Groups
  Description
Rosiglitazone

Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone

rosiglitazone: 4 mg daily for 6 months

Drospirenone/Ethinyl Estradiol

Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol

drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months

Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers

Participant Flow:   Overall Study
    Rosiglitazone   Drospirenone/Ethinyl Estradiol   Overweight/Obese Without PCOS   Lean Without PCOS
STARTED   23   23   0   0 
COMPLETED   17   20   0   0 
NOT COMPLETED   6   3   0   0 
Lost to Follow-up                5                2                0                0 
Withdrawal by Subject                1                0                0                0 
Headaches                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rosiglitazone

Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone

rosiglitazone: 4 mg daily for 6 months

Drospirenone/Ethinyl Estradiol

Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol

drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months

Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Total Total of all reporting groups

Baseline Measures
   Rosiglitazone   Drospirenone/Ethinyl Estradiol   Overweight/Obese Without PCOS   Lean Without PCOS   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   20   0   0   37 
Age 
[Units: Participants]
Count of Participants
         
Age           
<=18 years      16  94.1%      18  90.0%            34  91.9% 
Between 18 and 65 years      1   5.9%      2  10.0%            3   8.1% 
>=65 years      0   0.0%      0   0.0%            0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Age   15.7  (4.1)   16.2  (4.5)         16.0  (4.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      17 100.0%      20 100.0%            37 100.0% 
Male      0   0.0%      0   0.0%            0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   17   20         37 


  Outcome Measures

1.  Primary:   Peripheral Insulin Sensitivity at Baseline and 6 Months.   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Hepatic Insulin Sensitivity at Baseline and 6 Months.   [ Time Frame: Baseline and 6 months ]

3.  Primary:   Glucose Tolerance Status at Baseline and 6 Months.   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Total Fat Mass at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Total Testosterone at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Percent Body Fat at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Free Testosterone at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   SHBG at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

9.  Secondary:   DHEAS at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

10.  Secondary:   Delta Androstenedione at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

11.  Secondary:   Delta DHEA at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

12.  Secondary:   Delta 17-OHProg at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

13.  Secondary:   Delta 17-OHPreg at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

14.  Secondary:   Cholesterol at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

15.  Secondary:   HDL at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

16.  Secondary:   LDL at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

17.  Secondary:   Triglycerides at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

18.  Secondary:   Non-HDL Cholesterol at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

19.  Secondary:   Adiponectin at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

20.  Secondary:   Leptin at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

21.  Secondary:   Hs-CRP at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

22.  Secondary:   Morning Blood Pressure at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

23.  Secondary:   Night Blood Pressure at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The potential unblinding due to the rapid regulation of withdrawal bleeding which may have influenced the dropout rates;the short duration of treatment in contrast to clinical practice where treatment may be for several years.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Silva Arslanian
Organization: Children's Hospital of Pittsburgh of UPMC
phone: 412-692-6935


Publications of Results:

Responsible Party: Silva Arslanian, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00640224     History of Changes
Other Study ID Numbers: 0503013
2K24HD001357 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2008
First Posted: March 21, 2008
Results First Submitted: July 27, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017