To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
NCT ID:
NCT06142656
Condition:
Poly Cystic Ovary Syndrome
Conditions: Official terms:
Ovarian Cysts
Syndrome
Metformin
Vildagliptin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Metformin Hydrochloride tablet
Description:
Metformin Hydrochloride 850 mg oral tablet
Arm group label:
Metformin
Intervention type:
Drug
Intervention name:
Vildagliptin 50 MG
Description:
Vildagliptin 50 MG oral tablets
Arm group label:
Vildagliptin
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 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of
Health criteria.
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
October 6 university hospital
Address:
City:
Giza
Zip:
12585
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
ahmed M. A, phD
Phone:
01001749605
Contact backup:
Last name:
Hanan elhanafy
Phone:
01281084864
Start date:
November 25, 2023
Completion date:
May 1, 2024
Lead sponsor:
Agency:
October 6 University
Agency class:
Other
Source:
October 6 University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06142656
