Empagliflozin vs Metformin in PCOS

Sponsor
Hull University Teaching Hospitals NHS Trust
Study ID
NCT03008551
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Each participant will receive empagliflozin 25mg daily for 3 months.
  • Metformin — DRUG
    Each participant will receive metformin 1500mg daily for 3 months.

Study Details

This a randomised open-label parallel study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg daily for three months. The aim of the study is to examine the effect of empagliflozin on hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.

Key Dates

Start date
Aug 18, 2017
Status verified
Jul 2019
Primary completion
Apr 2, 2018
Completion
Apr 2, 2018

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Empagliflozin group
    Each participant will receive empagliflozin 25mg daily for 3 months
  • Active Comparator: Metformin group
    Each participant will receive metformin 1500mg daily for 3 months

Primary Outcome Measure

Endothelial function as measured by RHI (reactive hyperaemia index). [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]

Related Studies