PCOPhase 3NCT05601336
Dapagliflozin Versus Metformin and Their Combination in Polycystic Ovary Syndrome
A Phase 3 study testing Dapagliflozin 5 MG, Metformin Hydrochloride 1000 MG and Dapagliflozin/Metformin in people with PCO, run by Beni-Suef University at 1 site in Egypt.
Trial 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 women with PCOs. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- PCO
- What is being tested?
- Dapagliflozin 5 MG, Metformin Hydrochloride 1000 MG and Dapagliflozin/Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 30 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women are aged between 20 and 45 years
- polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Women With Polycystic Ovary Syndrome
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 women with PCOs.
Read the detailed description
It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 20 and 45 years, whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
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
- PCO
- Being tested
- Dapagliflozin 5 MG, Metformin Hydrochloride 1000 MG, Dapagliflozin/Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 5 MGDrug
Also called [Farxiga]
SGLT2 inhibitor
Metformin Hydrochloride 1000 MGDrug
Also called Glucophage 1000mg
metformin
Dapagliflozin/MetforminDrug
Also called Xigduo
SGLT2 inhibitor and metformin HCl extended-release
| Study group | Role | What they receive |
|---|---|---|
| metformin monotherapy | Active comparator | Glucophage 1000 once daily Receives: Drug: Metformin Hydrochloride 1000 MG |
| Dapagliflozin monotherapy . | Active comparator | Farxiga once per day Receives: Drug: Dapagliflozin 5 MG |
| metformin and dapagliflozin combined therapy | Active comparator | Xigduo once daily Receives: Drug: Dapagliflozin/Metformin |
| control group. | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA IR
Insulin resistance is assessed using HOMA IR
Measured: 3 months
Secondary outcomes (5)
Body weight changes
weight loss by Kg
Measured: 3 months
Fasting blood sugar (FBS)
Measured: 3 months
Total Testosterone (TT)
Measured: 3 months
lipid profile
Measured: 3 months
side effects
Number of patients will report nausea / diarrhea
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 May 2025
- Primary completion1 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Study director, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601336
- Sponsor's protocol ID
- FMBSUREC/04052025/Mahmoud
- Status last verified
- May 2025
- First submitted
- 15 Oct 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05601336
- Acronym / sponsor ID
- FMBSUREC/04052025/Mahmoud
- Conditions
- PCO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 women with PCOs.
Detailed description
It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 20 and 45 years, whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| metformin monotherapy | Active comparator | Drug: Metformin Hydrochloride 1000 MGGlucophage 1000 once daily |
| Dapagliflozin monotherapy . | Active comparator | Drug: Dapagliflozin 5 MGFarxiga once per day |
| metformin and dapagliflozin combined therapy | Active comparator | Drug: Dapagliflozin/MetforminXigduo once daily |
| control group. | No intervention | –control |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women are aged between 20 and 45 years
- polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 5 MGAlso: [Farxiga]SGLT2 inhibitor | Drug | Dapagliflozin monotherapy . |
| Metformin Hydrochloride 1000 MGAlso: Glucophage 1000mgmetformin | Drug | metformin monotherapy |
| Dapagliflozin/MetforminAlso: XigduoSGLT2 inhibitor and metformin HCl extended-release | Drug | metformin and dapagliflozin combined therapy |
Primary outcome
HOMA IR
Time frame: 3 months
Insulin resistance is assessed using HOMA IR
5 secondary outcomes
Body weight changes
Time frame: 3 months
Fasting blood sugar (FBS)
Time frame: 3 months
Total Testosterone (TT)
Time frame: 3 months
lipid profile
Time frame: 3 months
side effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for PCO
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Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beni-Suef University study director
Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 5 MG, Metformin Hydrochloride 1000 MG and Dapagliflozin/Metformin in people with PCO, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA IR (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.