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

NCT ID: NCT00396513

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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PCOS Statin Metformin Testosterone Menstrual cycle Lipids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Simvastatin

Intervention Type DRUG

Simvastatin and Metformin

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Leszek Pawelczyk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Scienses

Antoni J Duleba, MD

Role: STUDY_DIRECTOR

Yale University

Locations

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Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Beata E Banaszewska, MD PhD

Role: CONTACT

Phone: +48 618419412

Email: [email protected]

Robert Z Spaczynski, MD PhD

Role: CONTACT

Phone: +48 618419412

Email: [email protected]

References

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Xiong 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.

Reference Type DERIVED
PMID: 37462232 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21865358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19890022 (View on PubMed)

Other Identifiers

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1142/05

Identifier Type: -

Identifier Source: org_study_id