drugset / Trial / NCT02133755

Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study

NCT02133755

Phase 3 Unknown 60 enrolled IWK Health Centre
NaSingle-groupOpen-label

Summary

The primary aim of this study is to determine the effect of dopamine agonist therapy on insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is more significant in obese women with PCOS, even lean women can be insulin resistant. No current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may have a pathogenetic role in the development of PCOS. No study to date has assessed the impact of dopamine agonist therapy on IR in patients with PCOS.

Timeline

Start
2014-07
Primary completion
2015-07
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bromocriptine Small molecule 1.6 mg
Subject Bromocriptine Small molecule 3.2 mg