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

PHASE3CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

April 30, 2018

Study Completion Date

June 30, 2018

Conditions
Polycystic Ovary Syndrome (PCOS)
Interventions
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

Trial Locations (2)

10430

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta

40161

Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital, Bandung

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Dexa Medica Group

INDUSTRY

NCT01733459 - Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS) | Biotech Hunter | Biotech Hunter