Clinical trial · Interventional
The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial
NCT01072097CI-TRIAL-00005454completedN/AClinicalTrials.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)
This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS. We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.
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 |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Atorvastatin
- description
- 6 months atorvastatin 20mg/day treatment
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 6 months placebo treatment
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Androgen secretion
- timeFrame
- 0, 3, 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosed for PCOS (Rotterdam criteria) * aged 30-50 years * safe non-hormonal contraception Exclusion Criteria: * use of cholesterol lowering agents * use of antidepressants * use of cortisone medication (p.o.) * use of hormonal contraception * nursing * pregnancy * DM-T2 * liver disease * menopause * kidney or liver failure
References
Publications (2)
- DERIVEDXiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3. PMID 37462232
- DERIVEDPuurunen J, Piltonen T, Puukka K, Ruokonen A, Savolainen MJ, Bloigu R, Morin-Papunen L, Tapanainen JS. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23. PMID 24152688