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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) \>4, and self-reported oligomenorrhea (cycle length \>35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study.

I The study will include four groups; each group consists of 50 patients:-

* Group I (n=50) will be treated by metformin monotherapy.
* Group II (n=50) will be treated by Dapagliflozin monotherapy .
* Group III (n=50) will be treated by metformin and dapagliflozin combined therapy
* Group IV (n=50) will be a control group.

Conditions

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PCO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin monotherapy

Glucophage 1000 once daily

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride 1000 MG

Intervention Type DRUG

metformin

Dapagliflozin monotherapy .

Farxiga once per day

Group Type ACTIVE_COMPARATOR

Dapagliflozin 5 MG

Intervention Type DRUG

SGLT2 inhibitor

metformin and dapagliflozin combined therapy

Xigduo once daily

Group Type ACTIVE_COMPARATOR

Dapagliflozin/Metformin

Intervention Type DRUG

SGLT2 inhibitor and metformin HCl extended-release

control group.

placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dapagliflozin 5 MG

SGLT2 inhibitor

Intervention Type DRUG

Metformin Hydrochloride 1000 MG

metformin

Intervention Type DRUG

Dapagliflozin/Metformin

SGLT2 inhibitor and metformin HCl extended-release

Intervention Type DRUG

Other Intervention Names

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[Farxiga] Glucophage 1000mg Xigduo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes