Endometriosis
Conditions
Interventions
treatment group:Use danazol suppositories regularly
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. women aged 18-45 years,had sex; 2. Menstrual cycle of 25~35 days (including boundary value); 3. Have no willing to be pregnant in the next 6 months and consent to use non-hormonal contraceptives during the trial and within one month after the trial; 4. Clinical or pathological diagnosis of endometriosis associated pain; 5. Visual analogue scale (VAS) of pain caused by endometriosis (dysmenorrhea, dyspareunia, chronic pelvic pain) =4; 6. Voluntarily participate this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women without sexual life; 2. Patients with other uterine diseases, such as submucosal leiomyoma, uterine leiomyoma with single diameter =4cm, endometrial polyps with diameter > 1.5cm, endometrial hyperplasia, etc; 3. Patients who planned to have other endometriosis treatments, such us surgery, interventional therapy during the study period; 4. In addition to endometriosis, patients also suffered from chronic pain or frequently recurrent pain with any other causes and require treatment with analgesics; 5. Patients with contraindications to danazol suppository; 6. Patients with abnormal liver function and previous liver history judged clinically significant by investigators (ALT or AST >2 times the normal upper limit, or total bilirubin >1.5 times the normal upper limit); 7. Abnormal renal function, judged by the investigator to be clinically significant (serum creatinine (Scr) and blood UREA nitrogen (BUN)/urea (UREA) >2 times the normal upper limit); 8. Patients with hematological diseases who are not suitable for the study; 9. Patients who are currently enrolled in another clinical trial or have enrolled in another drug or medical device clinical trial within the past 3 months; 10. Patients who are deemed unsuitable for the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biberoglu and Behrman scale;endometriosis health profile-5;Patients’ Global Impression of Change (PGIC);incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJinhua Leng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed