Polycystic OvaryPhase 3NCT06405178
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
A Phase 3 study testing Metformin, Dapagliflozin and Dapagliflozin/Metformin in people with Polycystic Ovary, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary
- What is being tested?
- Metformin, Dapagliflozin and Dapagliflozin/Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2026to 1 Apr 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:
- oilgo and/or anovulation (infrequent or no ovulation),
- clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
- polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
Who cannot join
- Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
- Persistent hyperprolactinemia,
- thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL)
- patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
- Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, #kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
Read the detailed description
The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital.
- Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin 1000mg, group (B) Dapagliflozin 10mg, Group(C) Combined Dapagliflozin-Metformin 10/1000mg and group (D) with no adjuvant therapy (control group).
- The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
This treatment regimen will continue for three cycles unless positive pregnancy is achieved. No diet restriction will be recommended during the study or change in the lifestyle. The population will be asked to inform about any side effects that may happen during the study. A written informed consent will be obtained from each woman participating in the study.
- Conditions
- Polycystic Ovary
- Being tested
- Metformin, Dapagliflozin, Dapagliflozin/Metformin, Letrozole
- Keywords
- Sodium-Glucose Co-Transporter-2 Inhibitors, Letrozole, Ovulation, Polycystic Ovarian Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage 1000
Insulin Sensitizer
DapagliflozinDrug
Also called Forxiga
Sodium-Glucose Co-transporter-2
Dapagliflozin/MetforminDrug
Also called Xigduo
Anti diabetic drug
LetrozoleDrug
Also called femara
Aromataze inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Metformin 1000mg | Experimental | Not described Receives: Drug: Metformin; Drug: Letrozole |
| Dapagliflozin 10mg | Experimental | Not described Receives: Drug: Dapagliflozin; Drug: Letrozole |
| Dapagliflozin-Metformin 10/1000mg | Experimental | Not described Receives: Drug: Dapagliflozin/Metformin; Drug: Letrozole |
| control group. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Serum HCG positive
Measured: 3 cycles ( 3 months / one month for each cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Mar 2026
- Primary completion30 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic OvaryStudies 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
- Single blind
- Who is masked
- Participant
- 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
- Sara A Beni-Suef University, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405178
- Sponsor's protocol ID
- Xigiduo PCO
- Status last verified
- May 2026
- First submitted
- 4 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06405178
- Acronym / sponsor ID
- Xigiduo PCO
- Conditions
- Polycystic Ovary
- Keywords
- Sodium-Glucose Co-Transporter-2 Inhibitors, Letrozole, Ovulation, Polycystic Ovarian Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 May 2024 (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 the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
Detailed description
The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital.
- Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin 1000mg, group (B) Dapagliflozin 10mg, Group(C) Combined Dapagliflozin-Metformin 10/1000mg and group (D) with no adjuvant therapy (control group).
- The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
This treatment regimen will continue for three cycles unless positive pregnancy is achieved. No diet restriction will be recommended during the study or change in the lifestyle. The population will be asked to inform about any side effects that may happen during the study. A written informed consent will be obtained from each woman participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin 1000mg | Experimental | Drug: Metformin, Drug: Letrozole |
| Dapagliflozin 10mg | Experimental | Drug: Dapagliflozin, Drug: Letrozole |
| Dapagliflozin-Metformin 10/1000mg | Experimental | Drug: Dapagliflozin/Metformin, Drug: Letrozole |
| control group. | No intervention | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:
Key exclusion criteria (5 listed)
- Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
- Persistent hyperprolactinemia,
- thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL)
- patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
- Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, #kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant
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 |
|---|---|---|
| MetforminAlso: Glucophage 1000Insulin Sensitizer | Drug | Metformin 1000mg |
| DapagliflozinAlso: ForxigaSodium-Glucose Co-transporter-2 | Drug | Dapagliflozin 10mg |
| Dapagliflozin/MetforminAlso: XigduoAnti diabetic drug | Drug | Dapagliflozin-Metformin 10/1000mg |
| LetrozoleAlso: femaraAromataze inhibitor | Drug | Dapagliflozin 10mg, Dapagliflozin-Metformin 10/1000mg, Metformin 1000mg |
Primary outcome
Pregnancy
Time frame: 3 cycles ( 3 months / one month for each cycle)
Serum HCG positive
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 2 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sara A Beni-Suef University, MD principal investigator
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 Metformin, Dapagliflozin and Dapagliflozin/Metformin in people with Polycystic Ovary, 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 4 inclusion and 5 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 2 Jun 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?
Pregnancy (time frame: 3 cycles ( 3 months / one month for each cycle)). 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 2 Jun 2026.