Primary dysmenorrhea
Conditions
Interventions
Imrecoxib-ibuprofen group: Imrecoxib-ibuprofen
Ibuprofen-imrecoxib group:Ibuprofen-imrecoxib
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated and signed informed consent; 2. Women aged 18-45 years (including 18 and 45 years old); 3. The 6 menstrual cycles before screening were regular (28 ± 7 days); 4. The patient was diagnosed as primary dysmenorrhea, and the onset occurred within 5 years after menarche; 5. Moderate and severe dysmenorrhea occurred in 3 consecutive months before screening; 6. At baseline observation period, VASmax >= 40 mm (VASmax was the highest score in the overall VAS score of 0-72 h).
Exclusion criteria
Exclusion criteria: 1. Patients who were considered to have secondary dysmenorrhea and / or reproductive organ abnormalities or diseases, according to the relevant examination and / or previous diagnostic evaluation; 2. Analgesic drugs / measures were used as remedial treatment during the baseline observation period; 3. Patients with vomiting history within 3 menstrual periods before screening; 4. Patients with premenstrual pain but no menstrual pain within 3 months before screening; 5. Patients take analgesics (such as NSAIDs), sedatives, muscle relaxants, tricyclic antidepressants, psychodepressants and traditional Chinese medicine within 15 days before screening; 6. Patients with a history of alcohol dependence or abuse within 2 years; 7. Patients who are using intrauterine devices, and who have been injected with medroxyprogesterone, leuprolide acetate or other GnRH analogues, embedded with progesterone or other progesterone implants, or take oral contraceptives within 6 months before screening; 8. During the screening period, abnormal liver and kidney function (including ALT or ast > 1.5 times of the upper limit of normal value, Cr > 1.2 times of the upper limit of normal value); 9. Allergic to any nonsteroidal anti-inflammatory drugs (NSAIDs) and sulfonamides; 10. Existing active bleeding, ulcer and perforation in stomach or intestine; 11. History of cardiovascular and cerebrovascular diseases, including unstable angina pectoris, acute myocardial infarction, acute cerebral ischemia and cerebral infarction, coronary artery bypass surgery and other diseases; 12. Pregnancy, lactation or pregnancy plan within one year; 13. Participated in other clinical trials within 3 months before screening; 14. Patients with any factors considered unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue score (VAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Verbal rating scale (VRS);Overall assesment;Daily function impact;Rescue therapy rate;Dysmenorrhea leave rate; | — |
Countries
China
Contacts
Public ContactShuzhong Yao
Department of Obstetrics and Gynecology, The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed