Endometrial hyperplasia (EH)
Conditions
Interventions
Experimental group:Levonorgestrel-releasing intrauterine system (LNG-IUS): Patients who achieve endometrial regression upon completion of the therapeutic phase may, at their discretion, proceed to the
Controlled group:Therapeutic Intervention: Starting on days 11–16 of the menstrual cycle, oral dydrogesterone 20 mg/day for 14 days per cycle, for a total of 6 cycles
Preventive Intervention: Patients who respond effectively to treatment continue oral dydrogesterone until month 24.
Sponsors
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Premenopausal female between 30-50 years old; 2.Histologically confirmed diagnosis of endometrial hyperplasia without atypia (simple or complex hyperplasia); 3. Willing to receive progestogen treatment; 4. First-time (incident) diagnosis of endometrial hyperplasia without atypia at the time of enrollment; 5. Patients should return for regular follow-up and pathological examinations 6. Written informed consent obtained from the patient (or legally authorized representative) prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who refuse to take conservative treatment; 2. Contraindications of oral progestogen: Acute or chronic liver diseases, liver tumor, thrombotic disease, hypercoagulability, cardiovascular diseases; 3. Contraindications of LNG-IUS: Confirmed or suspected pregnancy, pelvic inflammation diseases, lower genital tract infection, endometritis, infected abortion history in past 3 months, acute cervicitis, cervical dysplasia, progestogen dependent tumor, abnormal uterine bleeding with unknown cause, congenital or acquired uterine abnormalities, inclusing myoma deforming the uterine cavity, acute liver diseases or liver tumor, allergic to ingredients of LNG-IUS; 4. Patients with malignant tumor of reproductive system, with abnormal cervical cytology results or with HR-HPV infection; 5. Patients with confirmed or suspected breast cancer or taking endocrinotherapy such as tamoxifen; 6. Vaginal bleeding with unknown reason; 7. Patients who participate in other clinical trials for the past 3 months; 8. Researchers believe the patients are unfit for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate after 6 months treatement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate of patient who achieved complete remission;Correlation between high-risk factors and recurrence;Correlation between the duration of preventive interventions and recurrence;Dropout rate of patients during therapeutic interventions;Dropout rate of patients during preventive interventions;Proportion of patients undergoing subsequent total hysterectomy;Medical costs;Healthcare resource utilization;Patient’s overall satisfaction score with treatment; | — |
Countries
China
Contacts
Public ContactZhu Lan/ Tong Jiali
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed