Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05200793
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8.8
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome (PCOS)	Drug: Empagliflozin 25 mg; Drug: Linagliptin 10 mg; Drug: Metformin 1500 mg	Phase 4

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

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 7, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin arm (control group) Patients will receive Metformin (1500 mg orally/day) for 12 weeks .	Drug: Metformin 1500 mg; 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); Other Names: Metformin
Active Comparator: Empagliflozin arm Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.	Drug: Empagliflozin 25 mg; 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); Other Names: Empagliflozin
Active Comparator: Linagliptin arm Patients will receive Linagliptin (10 mg orally/day) for 12 weeks	Drug: Linagliptin 10 mg; 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); Other Names: Linagliptin

Outcome Measures

Primary Outcome Measures

1. Fertility parameters [3-6 months]

   [luteinizing hormone (LH)

2. Follicle-stimulating hormone [3-6 months]

   FSH

3. Free androgen index [3-6 months]

   total testosterone & sex hormone binding globulin (SHBG)

4. Transvaginal ultrasonography [3-6 months]

   disappearance of PCOS

5. Menstrual diaries [3-6 months]

   regulate menses cycles

Secondary Outcome Measures

1. Metabolic parameters [3-6 months]

   Fasting blood glucose level

2. Lipid profile (metabolic parameters) [3-6 months]

   Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II

3. Inflammatory indices [3-6 months]

   Interleukin 6 or Toll Like receptor 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women diagnosed with PCOS according to National Institute of Health criteria.

2. Age: >18 <40 years.

3. Infertile women (primary or secondary infertility).

Exclusion Criteria:

1. Patients with history of diabetes mellitus (Type 1 or 2).

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.

3. Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)

4. Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).

5. 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.

6. 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.

7. Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).

8. Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…).

9. Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.

10. Eating disorders (anorexia, bulimia) or gastrointestinal disorders.

11. Having a history of bariatric surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University	Alexandria		Egypt	21521

Sponsors and Collaborators

• Alexandria University

Investigators

• Study Chair: Hanan N Abdel Hafez, PhD, Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University
• Principal Investigator: Ahmed I ElMallah, PhD, Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Ibrahim ElMallah, Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University, Alexandria University
• ClinicalTrials.gov Identifier: NCT05200793
• Other Study ID Numbers: 0201566
• First Posted: Jan 21, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Ibrahim ElMallah, Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University, Alexandria University: PCOS; Empagliflozin; Linagliptin; Metformin
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Metformin; Empagliflozin; Linagliptin

Study Results

No Results Posted as of Jan 21, 2022