PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Summary

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

Conditions

• Polycystic Ovary Syndrome (PCOS)
• Insulin Resistance

Interventions

DRUG

DLBS3233

DRUG

Metformin XR

DRUG

Placebo metformin

Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).

DRUG

Placebo DLBS3233

Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).

Sponsors & Collaborators

• Dexa Medica Group

  lead INDUSTRY

Principal Investigators

• Soehartono Ds, Prof. dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital, Surabaya, Indonesia.

• Arsana Wiyasa IW, Dr. dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital, Malang, Indonesia.

• Putu Doster Mahayasa, dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital, Denpasar, Indonesia.

• Syarief Taufik, dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia.

• Nusratuddin Abdullah, Dr. dr., SpOG-K, MARS · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital, Makasar, Indonesia.

• Iwan Darma Putra, dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital, Banjarmasin, Indonesia.

• Eddy Suparman, Prof. Dr. dr., SpOG-K · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital, Manado, 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

2014-10-31

Primary Completion

2019-02-28

Completion

2019-05-31

Countries

• Indonesia

Study Locations