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

NCT01733459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-07-26

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • 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

  • Wiryawan Permadi, Dr., dr., SpOG(K) · Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-04-30
Completion
2018-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733459 on ClinicalTrials.gov