Trial intelligence / Profile preview

Dapagliflozin in Polycystic Ovary Syndrome (DEAP)

NCT04213677Phase 3

Key facts

Status: Completed
Start: Mar 2020
Primary completion: Oct 2022
Countries: 1
Sponsor: Nanfang Hospital, Southern Medical University
Modality: Small Molecules

Drugs: dapagliflozin
Conditions: polycystic ovary syndrome (PCOS)

Overview

Phase 3, randomised, double-blind trial in polycystic ovary syndrome (PCOS) comparing Dapagliflozin with Placebo (2 arms). Primary endpoints: Improvement in insulin resistance at 12 weeks and Improvement in serum androgen at 12 weeks. Started Mar 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Dapagliflozin
Dapagliflozin 10mg po qd
Placebo
Placebo po qd

Who it enrols

Women aged 18-45 with PCOS and BMI >= 24 or HOMA-IR >= 2.5, excluding those with other endocrine disorders, recent use of antidiabetic or PCOS medications, and significant liver or kidney dysfunction.

Endpoints

Primary

Improvement in insulin resistance12 weeks
Improvement in serum androgen12 weeks

Secondary

Area under the curve of glucose during OGTT12 weeks
Area under the curve of insulin during OGTT12 weeks
Free testosterone12 weeks
Sex hormone binding globulin12 weeks
Total testosterone12 weeks
Dehydroepiandrosterone-sulfate12 weeks
Androstenedione12 weeks
Luteinizing hormone12 weeks

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