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Dydrogesterone in the Treatment of Endometrial Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03790215
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
shuwang, Peking Union Medical College Hospital

Study Description
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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
Endometrial Polyp Drug: Dydrogesterone 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
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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
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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 Name: Duphaston


Outcome Measures
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Primary Outcome Measures :
  1. Regression rate of endometrial polyps [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: three months after the starting of treatment ]
    Any side effects during the treatment


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790215


Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: shuwang, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03790215    
Other Study ID Numbers: EP-1
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Neoplasms
Polyps
Pathological Conditions, Anatomical
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs