Dydrogesterone in the Treatment of Endometrial Polyps

NCT ID: NCT03790215

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-31

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.

Conditions

Endometrial Polyp

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cohort for treatment

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.

Group Type: EXPERIMENTAL

Dydrogesterone

Intervention Type: DRUG

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

Interventions

Dydrogesterone

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

Intervention Type: DRUG

Other Intervention Names

Duphaston

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

shuwang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

EP-1

Identifier Type: -

Identifier Source: org_study_id