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Et ikke blindet randomiseret forsøg på effekten af metformin vs. metformin og p-piller vs. p-piller på glukosetolerance, insulinresistens, væksthormon og cortisol metabolisme ved polycystisk ovariesyndrom A non-blinded randomised trial on the effect of metformin vs. metformin and oral contraceptives vs. oral contraceptives on glucosetolerance, insulin resistance, growth hormone and cortisol metabolism in polycystic ovary syndrome

Et ikke blindet randomiseret forsøg på effekten af metformin vs. metformin og p-piller vs. p-piller på glukosetolerance, insulinresistens, væksthormon og cortisol metabolisme ved polycystisk ovariesyndrom A non-blinded randomised trial on the effect of metformin vs. metformin and oral contraceptives vs. oral contraceptives on glucosetolerance, insulin resistance, growth hormone and cortisol metabolism in polycystic ovary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004763-57-DK
Enrollment
Unknown
Registered
2007-02-28
Start date
2007-03-15
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

Trade Name: Metformin Product Name: Metformin Alpharma Pharmaceutical Form: Tablet Trade Name: Desorelle Product Name: Desorelle Pharmaceutical Form: Tablet

Sponsors

Odense University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Uregelmæssige menstruationer (cykluslængde >35 dage) eller anovulatoriske cykli (regelmæssig cyklus med manglende stigning af serum progesteron på dag 20-27) 2. Forhøjet frit testosteron > 0,035 nmol/l eller hirsutisme ved klinisk undersøgelse 3. Polycystiske æggestokke ved vaginal UL For at indgå skal kriterium 1 og 2 være opfyldt på samme tid. Alternativt skal kriterium 2 og 3 være opfyldt på samme tid. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Alder 25) Kendt diabetes mellitus Endokrinologisk eller anden behandlingskrævende sygdom Spiseforstyrrelse eller kendt psykiatrisk anamnese Medicinforbrug, som vides at påvirke parametre der undersøges i denne undersøgelse. Graviditet – eller planlagt graviditet inden for det næste år. Tidligere eller aktuel leverlidelse eller forhøjede leverparametre Tidligere eller aktuel hjertelidelse Non-kaukasier Tidligere tromboembolisk sygdom Storrygere med alder over 35 år BMI > 35 kg/m2 Kontraindikationer mod behandling – se indledning

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effects of oral contraceptives vs. metformin vs. metformin and oral contraceptives in patients with polycystic ovary syndrome on two points: Insulin resistance Glucose tolerance ;Secondary Objective: To compare the effects of oral contraceptives vs. metformin vs. metformin and oral contraceptives in patients with polycystic ovary syndrome on several points: BMI, WHR, LH, FSH, total and free testosterone, fasting blood sugar and c-peptid, urine-cortisol, body composition, frequency of hypoglycemia, diabetes and impaired glucose tolerance (IGT). To compare the effects of the 3 treatment types on subgroups of patients (e.g normal weight vs. over weight) ;Primary end point(s): The effects of oral contraceptives vs. metformin vs. metformin and oral contraceptives in patients with polycystic ovary syndrome on two points: Insulin resistance Glucose tolerance—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026