DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Endometrioma Clinical Trial

Official title: Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Status Completed

Clinical Trial Summary

This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.

Clinical Trial Description

There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100 mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. Study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period. ;

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Visual Analogue Pain Scale: Moderate or Severe Pain

• NCT number: NCT01942122
• Study type: Interventional
• Source: Dexa Medica Group
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2015
• Completion date: April 2021