CClinicalTrials.gg
Sign In
Status unknownNCT00396513Updated Nov 7, 2006

Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

An interventional study of Simvastatin and Simvastatin and Metformin in Polycystic Ovary Syndrome, sponsored by Poznan University of Medical Sciences. Status unknown at 1 site in Poland. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2006-11-07.

Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • PCOS
  • Statin
  • Metformin
  • Testosterone
  • Menstrual cycle
  • Lipids
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) 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

Exclusion Criteria:

  • elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugSimvastatin
  • DrugSimvastatin and Metformin
  • DrugMetformin
06

What researchers measure

Primary outcomes

  1. Serum testosterone

Secondary outcomes

  1. regularity of menstrual cycle

  2. serum lutropin

  3. serum follitropin

  4. serum lipids

  5. serum DHEAS

  6. serum SHBG

  7. serum insulin

07

Study locations

1 of 1 sites recruiting
  • Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
    Poznan, 60-184, Poland
    Recruiting
08

References and documents

Publications

  • Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment. J Clin Endocrinol Metab. 2011 Nov;96(11):3493-501. doi: 10.1210/jc.2011-0501. Epub 2011 Aug 24. PubMed 21865358 ↗
  • Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Comparison of simvastatin and metformin in treatment of polycystic ovary syndrome: prospective randomized trial. J Clin Endocrinol Metab. 2009 Dec;94(12):4938-45. doi: 10.1210/jc.2009-1674. Epub 2009 Nov 4. PubMed 19890022 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00396513
Lead sponsor
Poznan University of Medical Sciences
Collaborators
Yale University
First posted
Nov 7, 2006
Start date
Sep 2005
Last update
Nov 7, 2006

Study contacts

Beata E Banaszewska, MD PhD
Contact
bbeata@gpsk.am.poznan.pl
+48 618419412
Robert Z Spaczynski, MD PhD
Contact
rspaczynski@yahoo.com
+48 618419412
Leszek Pawelczyk, MD PhD
principal investigator · Poznan University of Medical Scienses
Antoni J Duleba, MD
study director · Yale University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Polycystic Ovary Syndrome→

Other studies from this sponsor

Poznan University of Medical Sciences

Start the discussion