NCT05601336

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

October 15, 2022

Last Update Submit

May 25, 2023

Conditions

PCO

Outcome Measures

Primary Outcomes (2)

  • ovulation

    folliculometry by ultrasound

    3 cycles ( 3 months / one month for each cycle)

  • Cummulative rate of pregnancy

    HCG test

    3 months

Secondary Outcomes (9)

  • Body weight changes

    3 months

  • changes of Menstrual cycle

    3 months

  • Fasting blood sugar (FBS)/ 2 hpp

    3 months

  • Free Androgen Index (FAI)

    3 months

  • Total Testosterone (TT)

    3 months

  • +4 more secondary outcomes

Study Arms (4)

metformin monotherapy

ACTIVE COMPARATOR

Glucophage 1000 once daily

Drug: Metformin Hydrochloride 1000 MG

Dapagliflozin monotherapy .

ACTIVE COMPARATOR

Farxiga once per day

Drug: Dapagliflozin 5 MG

metformin and dapagliflozin combined therapy

ACTIVE COMPARATOR

Xigduo once daily

Drug: Dapagliflozin/Metformin

control group.

NO INTERVENTION

placebo

Interventions

Dapagliflozin 5 MGDRUG

SGLT2 inhibitor

Also known as: [Farxiga]
Dapagliflozin monotherapy .
Metformin Hydrochloride 1000 MGDRUG

metformin

Also known as: Glucophage 1000mg
metformin monotherapy
Dapagliflozin/MetforminDRUG

SGLT2 inhibitor and metformin HCl extended-release

Also known as: Xigduo
metformin and dapagliflozin combined therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women are aged between 18 and 45 years
  • no pregnancy plan within the next 6 months
  • polycystic ovarian syndrome (PCOS), according to Rotterdam criteria

You may not qualify if:

  • congenital adrenal hyperplasia
  • poorly controlled thyroid disease
  • Taking antidiabetic drugs which can affect insulin resistance
  • chronic kidney disease and history of recurrent urinary tract infections
  • liver dysfunction (AST or ALT \> 3 times the upper limit of normal or GFR\<30 ml/min/1.73m2)
  • documented use of oral hormonal contraceptives and hormone-releasing implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

MeSH Terms

Interventions

dapagliflozinMetformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Beni-Suef University

    Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

    STUDY DIRECTOR

Central Study Contacts

Sara A Salem, MD

CONTACT

01272842226sara_abdallah100@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

October 15, 2022

First Posted

November 1, 2022

Study Start

January 15, 2022

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
within 36 months

Locations

EG(1)