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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Aspirin Enteric-coated Tablets,75mg/day,24 weeks |
|
| Drospirenone ethinyl estradiol | Active Comparator | Drospirenone ethinyl estradiol,one tablet/day for 21 consecutive days, 28 days as a cycle of use,24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 75mg, one time/day |
| |
| Drospirenone ethinyl estradiol |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengyun Chen, Master | Contact | 0086-13805727504 | 5504004@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhengyun Chen, Master | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 321006 | China |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C534342 | drospirenone and ethinyl estradiol combination |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Drug |
1 table/day, 21 consecutive days, 28 days as a cycle of use |
|
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |