Health TrialsbyHealthPanel

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

ConditionPoly Cystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorOctober 6 University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin Hydrochloride tablet

    Drug

    Metformin Hydrochloride 850 mg oral tablet

  • Vildagliptin 50 MG

    Drug

    Vildagliptin 50 MG oral tablets

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MetforminActive comparator 1 intervention
Group B: VildagliptinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of luteinizing hormone (LH)

serum luteinizing hormone (LH)

Time frame
at baseline and after 3 months
2

Concentration of Follicle-stimulating hormone

Serum Follicle-stimulating hormone

Time frame
at baseline and after 3 months
3

Concentration of Free androgen index

serum Free androgen index

Time frame
at baseline and after 3 months
4

Concentration of total testosterone

serum total testosterone

Time frame
at baseline and after 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

October 6 University

Lead sponsor

Source ClinicalTrials.gov
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