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Dydrogesterone in the Treatment of Endometrial Polyps

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03790215
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
10.9
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. Side effects [three months after the starting of treatment]

      Any side effects during the treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. women of childbearing age from 20 to 50 years old

    2. with or without menstrual changes:

    3. menostaxis (longer than 7 days)

    4. shortened menstrual cycles(less than 23 days)

    5. menorrhagia(more than twice as much as usual)

    6. abnormal vaginal bleeding(non-menstrual vaginal bleeding)

    7. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):

    8. typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen;

    9. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    shuwang, Associate Professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03790215
    Other Study ID Numbers:
    • EP-1
    First Posted:
    Dec 31, 2018
    Last Update Posted:
    Jan 22, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Neoplasms
    Polyps
    Dydrogesterone

    Study Results

    No Results Posted as of Jan 22, 2020