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Aspirin for the Management of Endometriosis-associated Pelvic Pain

NCT05156879 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

  • Pelvic Pain

Interventions

DRUG

Aspirin

75mg, one time/day

DRUG

Drospirenone ethinyl estradiol

1 table/day, 21 consecutive days, 28 days as a cycle of use

Sponsors & Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • Zhengyun Chen, Master · Women's Hospital School Of Medicine Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156879 on ClinicalTrials.gov