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Ethinylestradiol-levonorgestrel versus spironolactone-pioglitazone-metformin (SPIOMET) for adolescent girls with hyperinsulinemic androgen excess: effects on hepatic and visceral fat and on insulin sensitivity

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Trial Profile

Ethinylestradiol-levonorgestrel versus spironolactone-pioglitazone-metformin (SPIOMET) for adolescent girls with hyperinsulinemic androgen excess: effects on hepatic and visceral fat and on insulin sensitivity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2023

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At a glance

  • Drugs Ethinylestradiol/levonorgestrel (Primary) ; Metformin (Primary) ; Pioglitazone (Primary) ; Spironolactone (Primary)
  • Indications Hyperinsulinaemia; Polycystic ovary syndrome
  • Focus Pharmacodynamics
  • Acronyms OC vs SPIOMET

    • Most Recent Events

    • 08 Oct 2023 Results of post hoc pooled analysis assessing the pooled pre-treatment data of 65 adolescent girls with PCOS-without-obesity in three reported studies (ISRCTN 45546616; 29234515; 11062950) and the results of 24 adolescent girls with PCOS-without-obesity, who received pioglitazone (7.5 mg/d for 1 year) as part of a randomized combination treatment (with spironolactone and metformin) in two reported studies (29234515; 11062950), published in the Journal of Endocrinological Investigation.
    • 11 Dec 2016 Status changed from recruiting to active, no longer recruiting.
    • 11 Dec 2015 Planned End Date changed from 10 Dec 2016 to 30 Dec 2018 as per ISRCTN: Current Controlled Trials record.
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