NCT01733459

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

The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There will be 2 groups of treatment; each group will consist of 62 subjects with the treatment regimens : * Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily) * Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily) for 6 months of treatment. Clinical examination to evaluate the efficacy of the investigational drug will be performed at baseline and every interval of 1 month. Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography (USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and after Month 5th (Month 5.5th). Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive hormone levels) and safety, at baseline and Month 6th (end of study). General counseling on lifestyle modification will be provided to the subjects by the assigned Nutritionist. All study subjects should follow a lifestyle modification. Evaluation on subjects' performance on lifestyle modification will be conducted every follow-up visit by Investigator, but particularly at baseline, Month 3rd, and end of study (Month 6th) by the Nutritionist.

Conditions

• Polycystic Ovary Syndrome (PCOS)

Interventions

Type	Name	Description
DRUG	DLBS3233	1 DLBS3233 capsule 100 mg once daily for 6 months
DRUG	Metformin XR	1 Metformin XR caplet 750 mg twice daily for 6 months
DRUG	Placebo caplet of Metformin XR	1 placebo caplet of Metformin XR twice daily for 6 months
DRUG	Placebo capsule of DLBS3233	1 placebo capsule of DLBS3233 once daily for 6 months

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-04-01
• Completion: 2018-06-01
• First posted: 2012-11-27
• Last updated: 2018-07-26

Locations

2 sites across 1 country: Indonesia