Phase 4
N=46
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00640224 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Peripheral Insulin Sensitivity at Baseline and 6 Months. — 2.2; 2.1; 3.2; 2.0 mg/kg/min per uU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rosiglitazone (Drug); drospirenone/ethinyl estradiol (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- Female
- Sponsor
- Silva Arslanian
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Insulin Sensitivity at Baseline and 6 Months. |
2.2; 2.1; 3.2; 2.0 | — |
| PRIMARY Hepatic Insulin Sensitivity at Baseline and 6 Months. |
17.3; 17.4; 24.1; 16.8 | — |
| PRIMARY Glucose Tolerance Status at Baseline and 6 Months. |
15; 12; 2; 8; 15; 13 | — |
| SECONDARY Total Fat Mass at Baseline and 6 Months |
44.5; 48.0; 45.4; 49.1 | — |
| SECONDARY Total Testosterone at Baseline and 6 Months |
45.7; 34.5; 36.9; 30.6 | — |
| SECONDARY Percent Body Fat at Baseline and 6 Months |
46.2; 47.3; 46.6; 48.2 | — |
| SECONDARY Free Testosterone at Baseline and 6 Months |
10.7; 7.5; 7.7; 1.9 | — |
| SECONDARY SHBG at Baseline and 6 Months |
28.1; 22.7; 37.0; 154.5 | — |
| SECONDARY DHEAS at Baseline and 6 Months |
165.4; 212.2; 160.9; 197.5 | — |
| SECONDARY Delta Androstenedione at Baseline and 6 Months |
79.2; 82.6; 58.4; 117.0 | — |
| SECONDARY Delta DHEA at Baseline and 6 Months |
817.4; 1001.6; 643.4; 1092.1 | — |
| SECONDARY Delta 17-OHProg at Baseline and 6 Months |
207.0; 169.8; 178.0; 175.4 | — |
| SECONDARY Delta 17-OHPreg at Baseline and 6 Months |
912.8; 1024.3; 914.7; 1088.9 | — |
| SECONDARY Cholesterol at Baseline and 6 Months |
149.5; 156.5; 146.2; 185.2 | — |
| SECONDARY HDL at Baseline and 6 Months |
42.7; 40.9; 46.1; 55.0 | — |
| SECONDARY LDL at Baseline and 6 Months |
85.4; 85.9; 84.3; 97.7 | — |
| SECONDARY Triglycerides at Baseline and 6 Months |
106.7; 148.4; 79.2; 163.5 | — |
| SECONDARY Non-HDL Cholesterol at Baseline and 6 Months |
65.3; 70.6; 62.3; 87.6 | — |
| SECONDARY Adiponectin at Baseline and 6 Months |
6.5; 5.9; 11.6; 6.7 | — |
| SECONDARY Leptin at Baseline and 6 Months |
43.8; 40.6; 42.7; 46.8 | — |
| SECONDARY Hs-CRP at Baseline and 6 Months |
2.1; 1.7; 2.2; 3.8 | — |
| SECONDARY Morning Blood Pressure at Baseline and 6 Months |
108.2; 108.5; 58.1; 58.1; 107.5; 112.2 | — |
| SECONDARY Night Blood Pressure at Baseline and 6 Months |
117.5; 112.9; 63.0; 58.6; 115.2; 116.9 | — |
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).
Eligibility 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 ( 5.0 meq/L)
- Positive pregnancy test (serum)
Data sourced from ClinicalTrials.gov (NCT00640224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.