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Evaluation of Endpoints Used in Clinical Trials on Adenomyosis - A Systematic Review
Kiran Kumar Rathinam1, Justin Jacob Abraham1, Harish Karuppaiah1
1Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, India.
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.
Insights
Currently, no approved pharmacological treatments exist for adenomyosis. This review found limited drug research, with levonorgestrel-releasing intrauterine systems (LNG-IUS) and dienogest being the most studied therapies.
Area of Science:
- Gynecology
- Pharmacology
- Clinical Research
Background:
- Adenomyosis, a chronic gynecological condition, lacks approved pharmacological treatments despite its prevalence.
- Effective management strategies and standardized clinical endpoints for adenomyosis trials are urgently needed.
Approach:
- A systematic literature review of interventional trials for adenomyosis was conducted using PubMed and ClinicalTrials.gov.
- The search encompassed studies from 2001 to 2021, without time or language restrictions, to identify assessed drugs and common trial endpoints.
Key Points:
- Only approximately 15 drugs have been evaluated for adenomyosis management between 2001 and 2021.
- Levonorgestrel-releasing intrauterine systems (LNG-IUS) and dienogest were the most frequently investigated pharmacological agents.
- Commonly assessed endpoints included pain (VAS, NPRS), menstrual bleeding (hemoglobin, PBAC), uterine volume, and serum estradiol levels.
Conclusions:
- The limited number of drug evaluations highlights a significant gap in pharmacological research for adenomyosis.
- Existing clinical trials frequently measure pain, bleeding, uterine volume, and hormonal markers.
- There is a critical need to develop a comprehensive scoring system that integrates subjective symptoms and objective measures for improved adenomyosis evaluation.
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