- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04043221
Long Term Metformin in Women With Polycystic Ovary Syndrome
Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.
Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ljubljana, Slovenien, 1000
- University Medical Center Ljubljana
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- PCOS phenotype A
- BMI≥ 25kg/m2
- metformin 1000mg twice a day for at least one year
Exclusion Criteria:
- PCOS phenotype B, C, D
- BMI <25kg/m2
- had been treated with spironolactone or oral contraceptives alone or in combination with metformin
- had history of bariatric surgery
- became pregnant during the observation period
- had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
body weight
Tidsramme: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
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Primary outcome was change in body weight.
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The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
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menstrual frequency
Tidsramme: The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
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Primary outcome was change in menstrual frequency.
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The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
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free testosterone
Tidsramme: The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
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Primary outcome was change in levels of free testosterone.
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The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
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diabetes mellitus
Tidsramme: The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
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Primary outcome was development of diabetes mellitus.
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The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MET retro
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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