|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00640224 |
|
Date of registration:
|
18/03/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
|
|
Scientific title:
|
Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives |
|
Date of first enrolment:
|
March 2005 |
|
Target sample size:
|
75 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00640224 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Silva Arslanian, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Pittsburgh |
| | |
|
Key inclusion & exclusion criteria
|
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)
Age minimum:
10 Years
Age maximum:
20 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Polycystic Ovary Syndrome
|
|
Intervention(s)
|
|
Drug: drospirenone/ethinyl estradiol
|
|
Drug: rosiglitazone
|
|
Primary Outcome(s)
|
|
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance.
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on bone turnover
[Time Frame: 6 months]
|
|
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on cardiovascular health and inflammation
[Time Frame: 6 months]
|
|
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism
[Time Frame: 6 months]
|
|
To compare the markers of cardiovascular health and inflammation within the PCOS group to those in overweight females without PCOS and lean females without PCOS
[Time Frame: Baseline]
|
|
Secondary ID(s)
|
|
0503013
|
|
2K24HD001357
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|