Back to resultsDydrogesterone in the Treatment of Endometrial Polyps
Primary Purpose
Endometrial Polyp
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dydrogesterone
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Polyp
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cohort for treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Side effects
Any side effects during the treatment
Full Information
NCT ID
NCT03790215
First Posted
December 21, 2018
Last Updated
January 19, 2020
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03790215
Brief Title
Dydrogesterone in the Treatment of Endometrial Polyps
Official Title
Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Polyp
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cohort for treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Other Intervention Name(s)
Duphaston
Intervention Description
The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.
Primary Outcome Measure Information:
Title
Regression rate of endometrial polyps
Description
No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
Time Frame
three months after the starting of treatment
Title
Relapse rate of endometrial polyps
Description
Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment
Time Frame
six months after the starting of treatment
Secondary Outcome Measure Information:
Title
Side effects
Description
Any side effects during the treatment
Time Frame
three months after the starting of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dydrogesterone in the Treatment of Endometrial Polyps
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