The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
HOMA-IR reduction from baseline to Month 6th (end of study)
Andon Hestiantoro, dr., SpOG(K)
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia: National Agency of Drug and Food Control