Phase 3
N=36
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00283816 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Reduction in Abdominal Fat as Measured by Waist Circumference. — -3.9; -1.4 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Oral Contraceptive Pill (Drug); Lifestyle Management Program (Behavioral); Quality of Life Questionnaire (Behavioral); Oral Glucose Tolerance Test (Procedure); Blood work (Procedure); Abdominal Ultra Sound (Procedure); Dual-energy x-ray absorptiometry (DEXA scan) (Procedure); placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Abdominal Fat as Measured by Waist Circumference. |
-3.9; -1.4 | — |
| SECONDARY Change in Weight Post Minus Pre Intervention. |
-1.9; -1.2 | — |
| SECONDARY Total Testosterone Change |
-57.7; -27.6 | — |
| SECONDARY Change in Sex Hormone Binding Globulin (SHBG) |
-73.4; -58 | — |
Summary
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.
Eligibility Criteria
Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle.
Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight > 300 lbs.
Data sourced from ClinicalTrials.gov (NCT00283816). 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.