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Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Mini-Review Article

Evaluation of Endpoints Used in Clinical Trials on Adenomyosis - A Systematic Review

Author(s): Kiran Kumar Rathinam, Justin Jacob Abraham, Harish Karuppaiah, Heema Preethy Selvaraj, Sunita Samal and Melvin George*

Volume 18, Issue 2, 2023

Published on: 18 April, 2023

Page: [83 - 91] Pages: 9

DOI: 10.2174/1574887118666230329104546

Price: $65

Abstract

Adenomyosis lacks approved pharmacological treatment even after decades of its identification. We performed this study to review the status of clinical research on adenomyosis for finding an effective drug therapy and to identify the most common endpoints used in adenomyosis trials. A systematic search was performed in the PubMed and Clinicaltrials.gov registries to identify interventional trials for analysis without any time and language restrictions. Our search revealed that barely 15 drugs have been assessed for the management of adenomyosis from 2001 to 2021. Among these, LNG-IUS was found to be the most evaluated drug, followed by dienogest. In these trials, the most commonly assessed endpoints included VAS, NPRS for pain, haemoglobin and PBAC for menstrual bleeding, uterine volume, and serum estradiol. There appears to be a need for developing a comprehensive score that takes into consideration all disease symptoms as well as incorporates some objective elements to evaluate the disease.

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