NCT02280057

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

October 28, 2014

Last Update Submit

February 22, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSmetforminobesityrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Testosterone (Levels of free testosterone)

    Levels of free testosterone

    six months

Secondary Outcomes (1)

  • Insulin sensitivity (measured homeostasis model assessment (HOMA) index)

    Six months

Other Outcomes (1)

  • Body weight change

    Six months

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Metformin 850 mg x 2 in six months

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo 2 tablets daily for six months

Drug: Placebo

Interventions

MetforminDRUG

Metformin 1500 mg (=2 pills) per day in six months

Metformin
PlaceboDRUG

2 pills per day in six months; pills look like metformin pills

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • testosterone value above the upper normal limit and
  • oligo- or amenorrhea,

You may not qualify if:

  • periclimacteric gonadotrophin values,
  • hyperprolactinaemia,
  • diabetes mellitus,
  • impaired thyroid,
  • renal or hepatic function,
  • hormonal treatment,
  • pregnancy,
  • lactation or a wish for fertility treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecology Dept. Herning Hospital

Herning, 7400, Denmark

Location

Related Publications (4)

  • Trolle 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: 17766923RESULT

  • Trolle 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: 20189560RESULT

  • Greibe 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: 23857221RESULT

  • Madsen 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: 25736975RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Finn F Lauszus, MD, PhD

    Gyn Dept. Herning Hospital, Herning, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 31, 2014

Study Start

September 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)