Clinical trial · Interventional
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
NCT00365638CI-TRIAL-00000398completedN/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)
The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- serum testosterone
Secondary outcomes (6)
- measure
- serum lutropin
- measure
- serum follitropin
- measure
- serum lipids
- measure
- serum DHEA-S
- measure
- serum SHBG
- measure
- serum insulin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl) * Normal prolactin, TSH, 17-OH progesterone * No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly * Age 18-40 * Reliable use of birth control pill for at least 3 months and no plans of pregnancy Exclusion Criteria: * Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal * Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics. * Use of oral contraceptives and other steroid hormones 3 months prior to the study * Contraindications to oral contraceptives
References
Publications (3)
- RESULTDuleba AJ, Banaszewska B, Spaczynski RZ, Pawelczyk L. Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial. Fertil Steril. 2006 Apr;85(4):996-1001. doi: 10.1016/j.fertnstert.2005.09.030. Epub 2006 Mar 9. PMID 16580386
- 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
- DERIVEDBanaszewska B, Pawelczyk L, Spaczynski RZ, Dziura J, Duleba AJ. Effects of simvastatin and oral contraceptive agent on polycystic ovary syndrome: prospective, randomized, crossover trial. J Clin Endocrinol Metab. 2007 Feb;92(2):456-61. doi: 10.1210/jc.2006-1988. Epub 2006 Nov 14. PMID 17105841