drugset / Trial / NCT05156879

Aspirin for the Management of Endometriosis-associated Pelvic Pain

NCT05156879

RandomizedParallel-groupOpen-labelTreatment

Summary

Endometriosis-associated pelvic pain (EAPP) is common in endometriosis and pain control is an important goal of long-term management. Non-steroidal anti-inflammatory drugs and oral contraception are the two first line therapies for endometriosis. High quality study about aspirin for the EAPP is absent. In this study, the investigators hypothesis that aspirin is effective in controlling EAPP. A randomized, open, and controlled study will be implemented. "participants with EAPP with visual Analogue Scale(VAS)\>30 mm will be included and low dose aspirin(75mg/day) be prescribed. Yasmin(Drospirenone ethinyl estradiol tablet) will be used as positive control. The primary efficacy end points is the reduction of the pain score of EAPP at 24th week assessed with VAS score. Pelvic examination, sonography and blood test will be to performed to evaluate the lesion and coagulation function. The adverse event and medication compliance will be investigated. The aim of this study is to explore the efficacy and safety of low dose aspirin therapy in management of EAPP. This study will provide new options for the long-term management of endometriosis, which will help reduce the medical cost of endometriosis.

Timeline

Start
2021-12-23
Primary completion
2024-12
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 75 mg
Comparator Yasmin Unknown

Indications