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

Polycystic Ovary Syndrome (PCOS) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200793
• Other study ID #: 0201566
• Status: Recruiting
• Phase: Phase 4
• Start date: December 7, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2022
• Source: Alexandria University
• Contact: Haidy M Sami, Master
• Phone: +201015299642
• Email: gs-haidy.sami[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility parameters	[luteinizing hormone (LH)	3-6 months
Primary	Follicle-stimulating hormone	FSH	3-6 months
Primary	Free androgen index	total testosterone & sex hormone binding globulin (SHBG)	3-6 months
Primary	Transvaginal ultrasonography	disappearance of PCOS	3-6 months
Primary	Menstrual diaries	regulate menses cycles	3-6 months
Secondary	Metabolic parameters	Fasting blood glucose level	3-6 months
Secondary	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	3-6 months
Secondary	Inflammatory indices	Interleukin 6 or Toll Like receptor 2	3-6 months