Dapagliflozin Efficacy and Action in PCOS

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT04213677
Phase
PHASE3
Status
Completed

Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.
  • Placebo — DRUG
    Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Study Details

The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.

Key Dates

Start date
Mar 20, 2020
Status verified
Jan 2023
Primary completion
Oct 1, 2022
Completion
Nov 1, 2022

Study Design

Enrollment
165 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin (Participants will receive dapagliflozin 10mg po qd).
  • Placebo Comparator: Placebo
    Placebo (Participants will receive placebo po qd)

Primary Outcome Measure

Improvement in insulin resistance over 12 weeks [ Time Frame: Baseline and 12 weeks ]

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