Endometrial polyps
Conditions
Interventions
Treatment group:After TCRP surgery, ddrodrogesterone was taken at a dose of 10 mg twice a day for 10 days
After the first menstrual cramp after surgery, dydrogesterone was taken from the 14th day of menstruation, with a dose of 10mg, twice a day for 10 consecutive days
The method of taking after the second menstrual cramp is the same as that after the first menstrual cramp.
Control group:Only TCRP was performed
Sponsors
Women’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
Eligibility
Sex/Gender
Female
Age
18 Years to 46 Years
Inclusion criteria
Inclusion criteria: 1. Has signed and dated the informed consent form; 2. Female, at least 18 years old and under 46 years old at the time of screening; 3. Confirmed endometrial polyps by vaginal ultrasound examination at screening, and its image description conforms to "intrauterine cavity strong echo mass (one of the three diameters =10mm)"; The double endometrial thickness (without polyp measurements) should be <=18mm; 4. The maximum diameter of any endometrial polyp <50mm; 5. Undergo transcervical endometrial polyp excision surgery (TCRP); 6. In good overall health as evidenced by medical history, physical and gynaecological examinations, and laboratory test results (except for conditions related to endometrial polyps); 7. The results of the cervical smear are normal or not clinically significant, and no further follow-up is required. If a normal result has been documented in the subject's medical record within the previous 12 months, the Pap smear may be dispensed with. Human papillomavirus (HPV) testing may be used as an adjunct test in subjects with atypical squamous cells (ASCUS) of unclear significance. Subjects at ASCUS may be enrolled in the study if they test negative for a high-risk HPV strain. 8. Not pregnant, no birth plan within two years after TCRP surgery. Use of acceptable non-hormonal methods of contraception (such as male condoms, cervical caps, diaphragms, or contraceptive sponges, all in combination with spermicide) at the beginning of the study until the end of the study. If permanent contraception is achieved through the subject's bilateral tubal ligation (including Essure®) or the partner's vasectomy, a barrier method of contraception is not required.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (childbirth, miscarriage or lactation is less than 3 months from the time interval between the start of treatment); 2. Long-term treatment with all classes of steroid hormone drugs; Women who receive any medication that may be effective (such as estrogen or progestogen preparations, hormonal contraceptives, hormone-releasing contraceptive devices) during the three months prior to surgery are not suitable for inclusion in this study; 3. Current users of tamoxifen; 4. Patients with recurrent endometrial polyps combined with moderate to severe anemia; 5. Malignant genital tract tumors (including vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, uterine sarcoma, fallopian tube cancer, ovarian cancer and peritoneal mesothelioma, etc.) or breast cancer; 6. Contraindications to taking dydrogesterone: those who are allergic to dydrogesterone; History of severe liver disease, as long as the liver function value has not returned to normal, liver tumor (current or past history), Dubin Johnson syndrome, Potor's syndrome, jaundice. 7. Any disease, condition, or drug that may impair the function of a body system, resulting in altered absorption, excessive accumulation, metabolic impairment, or altered excretion process of the study drug, including but not limited to: Renal impairment (laboratory test values outside the scope of inclusion criteria); Elevated liver enzymes (presence of at least one of the following): Aspartate aminotransferase (GOT)/aspartate aminotransferase (AST) levels above 2 times the upper limit of normal (ULN) Alanine aminotransferase (GPT)/alanine aminotransferase (ALT) levels greater than 2-fold ULN Alkaline phosphatase (AP) levels exceeding 2-fold ULN Total bilirubin 1.5 times ULN chronic intestinal diseases such as Crohn's disease and ulcerative colitis; 8. Any disease or condition that may affect the conduct of the study or the interpretation of the results, including: Known severe coagulopathy; Anemia from a known cause other than abnormal uterine bleeding (AUB); Known hemoglobinopathy; Ultrasonography before screening and enrollment showed that one or more ovarian cysts were > 30mm in diameter, and ipsilateral ovarian cystic structures were present for more than 2 menstrual cycles; Unexplained ovarian tumors or pelvic masses requiring further diagnosis; Known or suspected uterine fibroids >50 mm; 9. Abuse of alcohol, drugs or drugs (e.g., psychotropic substances); 10. Receiving other treatments that may interfere with the conduct of the study or the interpretation of results, including: Gonadotropin-releasing hormone agonists (GnRHa) if not discontinued for at least 60 days prior to enrollment. Use of tranexamic acid, traditional Chinese medicine, or other medications against AUB for the treatment of menorrhagia, if not discontinued at the time of enrollment. Use of anticoagulants that were not discontinued at the time of enrollment. 11. Participate in another drug clinical study at the same time. Participation in another clinical study that may have an impact on the purpose of this study prior to study inclusion; 12. Persons closely associated with the research center (e.g., employees or students of the research center) or site personnel (e.g., close relatives of the investigator); 13. Inability to cooperate with the study procedures for any reason, such as: language comprehension disorder, mental illness, inability to go to the research center, poor compliance with online oper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first recurrence of endometrial polyps.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Patients' Bleeding Symptoms; | — |
Countries
China
Contacts
Public ContactHuang Xiufeng
Women’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
Outcome results
None listed