Dydrogesterone in the Treatment of Endometrial Polyps

Study Overview
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Brief Summary
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This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Detailed Description
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Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Official Title
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Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps

Conditions
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Endometrial Polyp

Intervention / Treatment
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* Drug: Dydrogesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women of childbearing age from 20 to 50 years old with or without menstrual changes: menostaxis (longer than 7 days) shortened menstrual cycles(less than 23 days) menorrhagia(more than twice as much as usual) abnormal vaginal bleeding(non-menstrual vaginal bleeding) with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle): typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen; atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness >1cm; Exclusion Criteria: no menses within half a year; surgery or drug treatment of endometrial lesions in the past half year; with current intrauterine device; combined with other acute gynecological inflammation; with clinically suspected malignant tumors; long-term use of oral contraceptives; with abnormal liver and kidney function; with benign or malignant breast tumors; with any systemic malignant tumor or a history of tumors; participants who are pregnant.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort for treatment<br>Participants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months. | Drug: Dydrogesterone<br>* The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.<br>* Other names: Duphaston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Any side effects during the treatment | three months after the starting of treatment |