Clinical trial NCT05200793: Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: PCOS
Empagliflozin
Linagliptin
Metformin
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Fertility parameters
timeFrame: 3-6 months
measure: Follicle-stimulating hormone
timeFrame: 3-6 months
measure: Free androgen index
timeFrame: 3-6 months
measure: Transvaginal ultrasonography
timeFrame: 3-6 months
measure: Menstrual diaries
timeFrame: 3-6 months
Secondary outcomes:
measure: Metabolic parameters
timeFrame: 3-6 months
measure: Lipid profile (metabolic parameters)
timeFrame: 3-6 months
measure: Inflammatory indices
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University
name: Hanan N Abdel Hafez, PhD
role: STUDY_CHAIR
affiliation: Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University
name: Ahmed I ElMallah, PhD
role: PRINCIPAL_INVESTIGATOR
References: