Dydrogesterone in the Treatment of Endometrial Polyps

Endometrial Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790215
• Other study ID #: EP-1
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Endometrial Polyp
• Polyps
• Uterine Neoplasms

Intervention

Drug:
• Dydrogesterone
The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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