Using aspirin to manage pelvic pain from endometriosis
Low Dose of Aspirin for the Management of Endometriosis-associated Pelvic Pain: a Randomized, Open, Controlled Trial
This study is testing whether low-dose aspirin can help reduce pelvic pain for people with endometriosis compared to a standard treatment over 24 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05156879 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of low-dose aspirin (75mg/day) in managing endometriosis-associated pelvic pain (EAPP). Participants with a pain score greater than 30mm on the Visual Analogue Scale (VAS) will be randomized to receive either aspirin or a positive control, Yasmin, over a 24-week period. The primary outcome will be the reduction in pain scores, assessed at the end of the study, alongside evaluations of lesions and coagulation function through pelvic examinations, sonography, and blood tests. The study aims to fill the gap in high-quality research regarding non-steroidal anti-inflammatory drugs for EAPP.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with endometriosis who experience dysmenorrhea or non-cyclical pelvic pain lasting more than three months with a VAS pain score greater than 30mm.
Not a fit: Patients with a clear surgical treatment plan, active bleeding, or contraindications to aspirin or oral contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective pain management option for patients suffering from endometriosis-associated pelvic pain.
How similar studies have performed: While there is limited high-quality research on aspirin for EAPP, this approach is novel and aims to explore its effectiveness in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital School of Medicine Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhengyun Chen, Master — Women's Hospital School Of Medicine Zhejiang University
- Study coordinator: Zhengyun Chen, Master
- Email: 5504004@zju.edu.cn
- Phone: 0086-13805727504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.