Phase 3
Completed N=36
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Source: ClinicalTrials.gov NCT00283816 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Reduction in Abdominal Fat as Measured by Waist Circumference. — -3.9; -1.4 cm
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.
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 | — |
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. Informational only — not medical advice.