NCT00317928

Brief Summary

Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2001

Typical duration for not_applicable

Status
unknown

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

August 1, 2001

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
Last Updated

October 11, 2006

Status Verified

August 1, 2001

First QC Date

April 24, 2006

Last Update Submit

October 10, 2006

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeMetforminMetabolic SyndromeHyperandrogenismOvulation

Interventions

MetforminDRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of PCOS
  • Age 20 - 45

You may not qualify if:

  • Diabetes
  • Hormonal treatment
  • Pregnancy, lactation
  • Periclimacteric

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeMetabolic SyndromeHyperandrogenism

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Ditte Trolle, MD

    Skejby University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 25, 2006

Study Start

August 1, 2001

Study Completion

September 1, 2004

Last Updated

October 11, 2006

Record last verified: 2001-08