Polycystic Ovary Syndrome (PCOS)Phase 4NCT05200793
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
A Phase 4 study testing Empagliflozin 25 mg, Linagliptin 10 mg and Metformin 1500 mg in people with Polycystic Ovary Syndrome (PCOS), run by Alexandria University at 1 site in Egypt.
Trial summary
The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Empagliflozin 25 mg, Linagliptin 10 mg and Metformin 1500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2021to 1 Sep 2022
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with PCOS according to National Institute of Health criteria.
- Age: >18 <40 years.
- Infertile women (primary or secondary infertility).
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 and uncontrolled endocrine or metabolic disease.
- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
- Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).
- Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
- Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
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- Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
- Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…).
- Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Having a history of bariatric surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria, 21521
Ahmed I ElMallah, PhD, +201001708794, ahmed.elmallah@alexu.edu.eg]
Hanan N Abdel Hafez, PhD
About this study
Official title: A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women
The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Read the detailed description
Patients with polycystic ovary syndrome will be randomized to three arms:
- Metformin (standard care)
- Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Empagliflozin 25 mg, Linagliptin 10 mg, Metformin 1500 mg
- Keywords
- PCOS, Empagliflozin, Linagliptin, Metformin
- 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.
Empagliflozin 25 mgDrug
Also called Empagliflozin
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
Linagliptin 10 mgDrug
Also called Linagliptin
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
Metformin 1500 mgDrug
Also called Metformin
This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
| Study group | Role | What they receive |
|---|---|---|
| Metformin arm (control group) | Active comparator | Patients will receive Metformin (1500 mg orally/day) for 12 weeks . Receives: Drug: Metformin 1500 mg |
| Empagliflozin arm | Active comparator | Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks. Receives: Drug: Empagliflozin 25 mg |
| Linagliptin arm | Active comparator | Patients will receive Linagliptin (10 mg orally/day) for 12 weeks Receives: Drug: Linagliptin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility parameters
[luteinizing hormone (LH)
Measured: 3-6 months
Follicle-stimulating hormone
FSH
Measured: 3-6 months
Free androgen index
total testosterone \& sex hormone binding globulin (SHBG)
Measured: 3-6 months
Transvaginal ultrasonography
disappearance of PCOS
Measured: 3-6 months
Menstrual diaries
regulate menses cycles
Measured: 3-6 months
Secondary outcomes (3)
Metabolic parameters
Fasting blood glucose level
Measured: 3-6 months
Lipid profile (metabolic parameters)
Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II
Measured: 3-6 months
Inflammatory indices
Interleukin 6 or Toll Like receptor 2
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Dec 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Alexandria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim ElMallah, Alexandria University
- Investigators
- Hanan N Abdel Hafez, PhD, Study chair, Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura UniversityAhmed I ElMallah, PhD, Principal investigator, Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200793
- Sponsor's protocol ID
- 0201566
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women
- ClinicalTrials.gov ID
- NCT05200793
- Acronym / sponsor ID
- 0201566
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, Empagliflozin, Linagliptin, Metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 21 Jan 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 study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Detailed description
Patients with polycystic ovary syndrome will be randomized to three arms:
- Metformin (standard care)
- Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin arm (control group) | Active comparator | Drug: Metformin 1500 mgPatients will receive Metformin (1500 mg orally/day) for 12 weeks . |
| Empagliflozin arm | Active comparator | Drug: Empagliflozin 25 mgPatients will receive Empagliflozin (25 mg orally/day) for 12 weeks. |
| Linagliptin arm | Active comparator | Drug: Linagliptin 10 mgPatients will receive Linagliptin (10 mg orally/day) for 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women diagnosed with PCOS according to National Institute of Health criteria.
- Age: >18 <40 years.
- Infertile women (primary or secondary infertility).
Key exclusion criteria (11 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 and uncontrolled endocrine or metabolic disease.
- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
- Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).
- Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
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 |
|---|---|---|
| Empagliflozin 25 mgAlso: EmpagliflozinThis study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS) | Drug | Empagliflozin arm |
| Linagliptin 10 mgAlso: LinagliptinThis study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS) | Drug | Linagliptin arm |
| Metformin 1500 mgAlso: MetforminThis study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS) | Drug | Metformin arm (control group) |
Primary outcome
Fertility parameters
Time frame: 3-6 months
[luteinizing hormone (LH)
Follicle-stimulating hormone
Time frame: 3-6 months
FSH
Free androgen index
Time frame: 3-6 months
total testosterone \& sex hormone binding globulin (SHBG)
Transvaginal ultrasonography
Time frame: 3-6 months
disappearance of PCOS
Menstrual diaries
Time frame: 3-6 months
regulate menses cycles
3 secondary outcomes
Metabolic parameters
Time frame: 3-6 months
Lipid profile (metabolic parameters)
Time frame: 3-6 months
Inflammatory indices
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Hanan N Abdel Hafez, PhD study chair
Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University
Ahmed I ElMallah, PhD principal investigator
Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 mg, Linagliptin 10 mg and Metformin 1500 mg in people with Polycystic Ovary Syndrome (PCOS), run by Alexandria 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haidy M Sami, Master (+201015299642, gs-haidy.sami@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility parameters (time frame: 3-6 months). The study lists 5 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 21 Jan 2022.