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Status unknownNCT00317928Updated Oct 11, 2006

Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

An interventional study of Metformin in Polycystic Ovary Syndrome, sponsored by Aarhus University Hospital Skejby. Status unknown. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2006-10-11.

Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic Ovary Syndrome
  • Metformin
  • Metabolic Syndrome
  • Hyperandrogenism
  • Ovulation
03

In context

Polycystic Ovary Syndrome

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

This study's enrollment of 50 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of PCOS
  • Age 20 - 45

Exclusion Criteria:Diabetes

  • Diabetes
  • Hormonal treatment
  • Pregnancy, lactation
  • Periclimacteric
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
50 participants

Interventions

  • DrugMetformin
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00317928
Lead sponsor
Aarhus University Hospital Skejby
Collaborators
Regional Hospital Holstebro, Aarhus University Hospital
First posted
Apr 25, 2006
Start date
Aug 2001
Completion
Sep 2004
Last update
Oct 11, 2006

Study contacts

Ditte Trolle, MD
principal investigator · Skejby University Hospital, Aarhus, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2001. You cannot join it, but the record below documents what was studied.

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