Spots Global Cancer Trial Database for PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

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Trial Identification

Brief Title: PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Official Title: Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility

Study ID: NCT01999686

Conditions

Polycystic Ovary Syndrome (PCOS)

Insulin Resistance

Interventions

Study Description

Brief 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.

Detailed Description: There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following: * Treatment I : DLBS3233 100 mg once daily * Treatment II : Metformin XR 750 mg twice daily * Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily. Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th). Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study. Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.

Keywords

Polycystic ovarium syndrome

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital, Banjarmasin, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital, Denpasar, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital, Makasar, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital, Malang, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital, Manado, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, , Indonesia

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital., Surabaya, , Indonesia

Contact Details

Name: Soehartono Ds, Prof. dr., SpOG-K

Affiliation: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital, Surabaya, Indonesia.