Aspirin for the Management of Endometriosis-associated Pelvic Pain

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05156879

Collaborator

(none)

220

Enrollment

Location

Arms

41.3

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain	Drug: Aspirin Drug: Drospirenone ethinyl estradiol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 23, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

visual Analogue Scale [baseline , 12 weeks after treatment , and 24 weeks of treatment]
a scale with 0-100 mm values, higher scores mean a worse outcome

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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