Endometrial Polyp Clinical Trial
Official title:
Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
Verified date | January 2020 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 31, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. women of childbearing age from 20 to 50 years old 2. with or without menstrual changes: 1. menostaxis (longer than 7 days) 2. shortened menstrual cycles(less than 23 days) 3. menorrhagia(more than twice as much as usual) 4. abnormal vaginal bleeding(non-menstrual vaginal bleeding) 3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle): 1. typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen; 2. atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness >1cm; Exclusion Criteria: 1. no menses within half a year; 2. surgery or drug treatment of endometrial lesions in the past half year; 3. with current intrauterine device; 4. combined with other acute gynecological inflammation; 5. with clinically suspected malignant tumors; 6. long-term use of oral contraceptives; 7. with abnormal liver and kidney function; 8. with benign or malignant breast tumors; 9. with any systemic malignant tumor or a history of tumors; 10. participants who are pregnant. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regression rate of endometrial polyps | No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound | three months after the starting of treatment | |
Primary | Relapse rate of endometrial polyps | Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment | six months after the starting of treatment | |
Secondary | Side effects | Any side effects during the treatment | three months after the starting of treatment |
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