of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

Sponsor
Beni-Suef University
Study ID
NCT05601336
Phase
PHASE3
Status
Unknown

Conditions

  • PCO

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with PCOs.

Key Dates

Start date
Jan 15, 2022
Status verified
May 2023
Primary completion
Jul 30, 2023
Completion
Jul 30, 2023

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: metformin monotherapy
    Glucophage 1000 once daily
  • Active Comparator: Dapagliflozin monotherapy .
    Farxiga once per day
  • Active Comparator: metformin and dapagliflozin combined therapy
    Xigduo once daily
  • No Intervention: control group.
    placebo

Primary Outcome Measure

ovulation [ Time Frame: 3 cycles ( 3 months / one month for each cycle) ]

Central Contacts