NCT01999686

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

Detailed description

There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following: * Treatment I : DLBS3233 100 mg once daily * Treatment II : Metformin XR 750 mg twice daily * Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily. Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th). Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study. Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.

Conditions

• Polycystic Ovary Syndrome (PCOS)
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	DLBS3233
DRUG	Metformin XR
DRUG	Placebo metformin	Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).
DRUG	Placebo DLBS3233	Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-02-01
• Completion: 2019-05-01
• First posted: 2013-12-03
• Last updated: 2019-05-28

Locations

7 sites across 1 country: Indonesia