Phase 3
N=42
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00714233 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification — 10; 11; 11; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Oral Contraceptive Pills (Yasmin) (Drug); Lifestyle Modification (Behavioral); placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Apr 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification |
10; 11; 11; 10 | — |
| SECONDARY Weight Loss in Lifestyle Intervention Group |
-1.1 | <0.05 sig |
| SECONDARY Change in Free Androgen Index (FAI) |
-0.1; -16.7; -13.7; 1.2 | — |
| SECONDARY Change in SHBG |
2.6; 77; 17.6; 2 | — |
| SECONDARY Triglyceride Concentration by Treatment Group |
-22.3; 4.6; 2.2; -6.6 | — |
| SECONDARY Change in Fasting Glucose |
-6.7; 6.9; 0.4; -1.1 | — |
Summary
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:
1. reduce fasting glucose levels
2. reduce androgen hormone levels
3. improve sex steroid binding, and
4. improve lipids (fatty substances in the blood)
Eligibility Criteria
Inclusion Criteria
- Menstrual irregularity defined as cycle length > 45 days
- Overweight as BMI > 25
- Clinical evidence of hirsuitism or acne
- Testosterone > 50ng/dL
Exclusion Criteria
- History of diabetes mellitus
- History of Cushing's disease
- History of hyperprolactinemia
- Untreated hypo or hyperthyroidism
- History of adrenal hyperplasia
- Significant renal impairment
- Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
- Exercise > 10 hours per week
Data sourced from ClinicalTrials.gov (NCT00714233). 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.