Clinical trial · Interventional
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
NCT00151411CI-TRIAL-00032172completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle Intervention | Behavioral | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Metformin
- interventionNames
- Drug: Metformin
- Behavioral: Lifestyle Intervention
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
- Behavioral: Lifestyle Intervention
Primary outcomes (1)
- measure
- Change in Testosterone After 6 Months of Treatment
- timeFrame
- baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year * Elevated testosterone levels * General good health * Off of current medications which may confound response to study medications Exclusion Criteria: * Pregnancy * Lactose Intolerance * Medical Contraindications * Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests * Diabetes, liver, heart, kidney or uncorrected thyroid disease
References
Publications (2)
- DERIVEDLadson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048. PMID 21704212
- DERIVEDLadson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30. PMID 21193187