NCT05156879

Aspirin for the Management of Endometriosis-associated Pelvic Pain

Low Dose of Aspirin for the Management of Endometriosis-associated Pelvic Pain: a Randomized, Open, Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.However, there is currently a lack of high-quality clinical studies of nonsteroidal anti-inflammatory analgesic in controlling EAPP. The aim of this study is to explore the efficacy and safety of low dose aspirin therapy in management of EAPP. In this study, the investigators hypothesis that aspirin is effective in controlling EAPP. A randomized, open, and controlled study will be implemented. Subjects were recruited in strict accordance the inclusion and exclusion criteria at the outpatient clinic. Patients with EAPP with visual Analogue Scale(VAS:0-100mm）\>30mm will be included. Eligible subjects were randomized according to a computer-generated randomization schedule to to receive aspirin（75mg/day）or Yasmin(Drospirenone ethinyl estradiol tablet) in a ratio of 1:1. Specific doctors will be designated for the disease diagnosis and ultrasonic examination.The investigators were guided by EAPP pain score and drug use management. 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 specification of the CONSORT case report system will be implemented. Sample size assessment according equivalence study.Follow-up and loss cases were strictly controlled. A two-sided test will performed with beta=0.80 and αlpha=0.025. The expected loss rate is calculated at 15%. 220 cases will be enrolled with 110 cases in each group. The study will be accepted regular monitoring and inspection.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Aspirin	75mg, one time/day
DRUG	Drospirenone ethinyl estradiol	1 table/day, 21 consecutive days, 28 days as a cycle of use

Timeline

• Start date: 2021-12-23
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2021-12-14
• Last updated: 2022-01-24

Locations

1 site across 1 country: China