Poly Cystic Ovary SyndromePhase 2/3NCT06142656
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
A Phase 2/3 study testing Metformin Hydrochloride tablet and Vildagliptin 50 MG in people with Poly Cystic Ovary Syndrome, run by October 6 University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Poly Cystic Ovary Syndrome
- What is being tested?
- Metformin Hydrochloride tablet and Vildagliptin 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2023to 1 Feb 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
Who cannot join
- Patients with history of diabetes mellitus (Type 1 or 2).
- Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
- Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed hussein contact
Egypt1 site, 1 recruiting
- Recruiting
October 6 university hospital
Giza, 12585
ahmed M. A, phD, 01001749605
Hanan elhanafy, 01281084864
About this study
Official title: Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM
- Conditions
- Poly Cystic Ovary Syndrome
- Being tested
- Metformin Hydrochloride tablet, Vildagliptin 50 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride tabletDrug
Metformin Hydrochloride 850 mg oral tablet
Vildagliptin 50 MGDrug
Vildagliptin 50 MG oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Not described Receives: Drug: Metformin Hydrochloride tablet |
| Vildagliptin | Active comparator | Not described Receives: Drug: Vildagliptin 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of luteinizing hormone (LH)
serum luteinizing hormone (LH)
Measured: at baseline and after 3 months
Concentration of Follicle-stimulating hormone
Serum Follicle-stimulating hormone
Measured: at baseline and after 3 months
Concentration of Free androgen index
serum Free androgen index
Measured: at baseline and after 3 months
Concentration of total testosterone
serum total testosterone
Measured: at baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start25 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, engy wahsh, October 6 University
- Investigators
- ahmed hussein, PhD, Principal investigator, october 6 university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142656
- Sponsor's protocol ID
- PRC-Ph-2307004
- Status last verified
- Jul 2025
- First submitted
- 13 Nov 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06142656
- Acronym / sponsor ID
- PRC-Ph-2307004
- Conditions
- Poly Cystic Ovary Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Nov 2023 (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.
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin Hydrochloride tablet |
| Vildagliptin | Active comparator | Drug: Vildagliptin 50 MG |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
Key exclusion criteria (4 listed)
- Patients with history of diabetes mellitus (Type 1 or 2).
- Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
- Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders
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 |
|---|---|---|
| Metformin Hydrochloride tabletMetformin Hydrochloride 850 mg oral tablet | Drug | Metformin |
| Vildagliptin 50 MGVildagliptin 50 MG oral tablets | Drug | Vildagliptin |
Primary outcome
Concentration of luteinizing hormone (LH)
Time frame: at baseline and after 3 months
serum luteinizing hormone (LH)
Concentration of Follicle-stimulating hormone
Time frame: at baseline and after 3 months
Serum Follicle-stimulating hormone
Concentration of Free androgen index
Time frame: at baseline and after 3 months
serum Free androgen index
Concentration of total testosterone
Time frame: at baseline and after 3 months
serum total testosterone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen 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.
ahmed hussein contact
ahmed hussein, PhD principal investigator
october 6 university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin Hydrochloride tablet and Vildagliptin 50 MG in people with Poly Cystic Ovary Syndrome, run by October 6 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed hussein, phD (01001749605, ahmedhussein.med@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of luteinizing hormone (LH) (time frame: at baseline and after 3 months). The study lists 4 primary outcomes in all. 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 30 Jul 2025.