Aspirin for the Management of Endometriosis-associated Pelvic Pain

NCT05156879 | Unknown Phase 4

• 1 other identifier: IRB-20210267-R
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tenderness

  baseline , 12 weeks of treatment , and 24 weeks of treatment

• size of endometrioid lesions

  baseline , 12 weeks of treatment , and 24 weeks of treatment

• C reactive protein

  baseline , 12 weeks of treatment , and 24 weeks of treatment

• carbohydrate antigen 125

  baseline , 12 weeks of treatment , and 24 weeks of treatment

• platelets counts

  baseline , 12 weeks of treatment , and 24 weeks of treatment

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin Enteric-coated Tablets，75mg/day，24 weeks

Drug: Aspirin

Drospirenone ethinyl estradiol

ACTIVE COMPARATOR

Drospirenone ethinyl estradiol，one tablet/day for 21 consecutive days, 28 days as a cycle of use，24 weeks

Drug: Drospirenone ethinyl estradiol

Interventions

Aspirin DRUG

75mg, one time/day

Aspirin

Drospirenone ethinyl estradiol DRUG

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

Drospirenone ethinyl estradiol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 321006, China

RECRUITING

MeSH Terms

Conditions

Pelvic Pain

Interventions

Aspirin; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Zhengyun Chen, Master

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengyun Chen, Master

CONTACT

0086-13805727504; 5504004@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: December 23, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)