Dydrogesterone in the Treatment of Endometrial Polyps

Phase 4

Completed

• Conditions: Endometrial Polyp
• Interventions: Drug: Dydrogesterone

• Registration Number: NCT03790215
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-02-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort for treatment	Dydrogesterone	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.

Primary Outcome Measures

Name	Time	Method
Regression rate of endometrial polyps	three months after the starting of treatment	No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
Relapse rate of endometrial polyps	six months after the starting of treatment	Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment

Secondary Outcome Measures

Name	Time	Method
Side effects	three months after the starting of treatment	Any side effects during the treatment

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China