drugset / Trial / NCT01733459

Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

NCT01733459 ↗

Phase 3 Completed 124 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.

Timeline

Start
2013-03
Primary completion
2018-04
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS3233 Traditional medicine (herbal / TCM) 100 mg Oral
Comparator Metformin Small molecule 750 mg Oral