Clinical trial · Interventional
Trial With Metformin in Women With Polycystic Ovary Syndrome
Randomized, Cross-over Trial With Metformin in Women With Polycystic Ovary Syndrome
NCT02280057CI-TRIAL-00026111completedPhase 4ClinicalTrials.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 investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- Metformin 850 mg x 2 in six months
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo 2 tablets daily for six months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Testosterone (Levels of free testosterone)
- timeFrame
- six months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * testosterone value above the upper normal limit and * oligo- or amenorrhea, Exclusion Criteria: * periclimacteric gonadotrophin values, * hyperprolactinaemia, * diabetes mellitus, * impaired thyroid, * renal or hepatic function, * hormonal treatment, * pregnancy, * lactation or a wish for fertility treatment.
References
Publications (4)
- RESULTTrolle B, Flyvbjerg A, Kesmodel U, Lauszus FF. Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. Hum Reprod. 2007 Nov;22(11):2967-73. doi: 10.1093/humrep/dem271. Epub 2007 Aug 31. PMID 17766923
- RESULTTrolle B, Lauszus FF, Frystyk J, Flyvbjerg A. Adiponectin levels in women with polycystic ovary syndrome: impact of metformin treatment in a randomized controlled study. Fertil Steril. 2010 Nov;94(6):2234-8. doi: 10.1016/j.fertnstert.2010.01.057. Epub 2010 Mar 2. PMID 20189560
- RESULTGreibe E, Trolle B, Bor MV, Lauszus FF, Nexo E. Metformin lowers serum cobalamin without changing other markers of cobalamin status: a study on women with polycystic ovary syndrome. Nutrients. 2013 Jul 5;5(7):2475-82. doi: 10.3390/nu5072475. PMID 23857221
- RESULTMadsen HN, Lauszus FF, Trolle B, Ingerslev HJ, Torring N. Impact of metformin on anti-Mullerian hormone in women with polycystic ovary syndrome: a secondary analysis of a randomized controlled trial. Acta Obstet Gynecol Scand. 2015 May;94(5):547-51. doi: 10.1111/aogs.12605. Epub 2015 Mar 4. PMID 25736975