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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Pain
• Intervention / Treatment: Drug: Aspirin; Drug: Drospirenone ethinyl estradiol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhengyun Chen, Master; Phone Number: 0086-13805727504; Email: 5504004@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 321006
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Chen Zhengyun; Phone Number: 0086-13805727504; Email: 5504004@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Dysmenorrhea or non-cyclical pelvic pain lasts for more than 3 months, and the VAS pain score is larger than 30mm
• diagnosed as endometriosis
• Willing to participate in clinical trials and sign informed consent

Exclusion Criteria:

• Those who have a clear surgical treatment plan due to various diseases within 6 months
• Suspected or suffering from malignant tumor
• Hemoglobin less than 8g/dl
• women with contraindications to the use of aspirin or oral contraceptives
• with other painful disease other than endometriosis
• Active bleeding from other areas or undiagnosed abnormal vaginal bleeding
• drug adminstration within 3 months including oral contraceptives, dienogest, Mirena or GnRH-a preparations, analgesics/Chinese medicines or proprietary Chinese medicines, etc.
• Pregnancy status or breastfeeding
• Any disease or symptom that may affect the implementation of the study or the interpretation of the results
• Participate in other clinical trials at the same time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspirin; Aspirin Enteric-coated Tablets，75mg/day，24 weeks	Drug: Aspirin; 75mg, one time/day
Active Comparator: Drospirenone ethinyl estradiol; Drospirenone ethinyl estradiol，one tablet/day for 21 consecutive days, 28 days as a cycle of use，24 weeks	Drug: Drospirenone ethinyl estradiol; 1 table/day, 21 consecutive days, 28 days as a cycle of use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual Analogue Scale	a scale with 0-100 mm values, higher scores mean a worse outcome	baseline , 12 weeks after treatment , and 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tenderness	Tenderness during pelvic examination from 1 to 4,higher scores mean a worse outcome	baseline , 12 weeks of treatment , and 24 weeks of treatment
size of endometrioid lesions	endometrioid lesions detected by sonorgraphy	baseline , 12 weeks of treatment , and 24 weeks of treatment
C reactive protein	a biomarker of inflammation	baseline , 12 weeks of treatment , and 24 weeks of treatment
carbohydrate antigen 125	a biomarker of endometriosis	baseline , 12 weeks of treatment , and 24 weeks of treatment
platelets counts	associated with inflammation and wound healing	baseline , 12 weeks of treatment , and 24 weeks of treatment

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Zhengyun Chen, Master, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Natriuretic Agents; Diuretics; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Aspirin; Estradiol; Ethinyl Estradiol; Drospirenone; Drospirenone and ethinyl estradiol combination
• Other Study ID Numbers: IRB-20210267-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No