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CompletedNCT03790215Updated Jan 22, 2020

Dydrogesterone in the Treatment of Endometrial Polyps

A Phase 4 interventional study of Dydrogesterone in Endometrial Polyp, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Endometrial Polyp
03

In context

Uterine Neoplasms

255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.

This study's enrollment of 60 is above the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.

Browse Uterine Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • DrugDydrogesterone

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

    Also known as: Duphaston

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: three months after the starting of treatment

  2. 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

    Time frame: six months after the starting of treatment

Secondary outcomes

  1. Side effects

    Any side effects during the treatment

    Time frame: three months after the starting of treatment

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, 100730, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03790215
Lead sponsor
Peking Union Medical College Hospital
Responsible party
shuwang (Associate Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Dec 31, 2018
Start date
Feb 1, 2019
Primary completion
Sep 30, 2019
Completion
Dec 31, 2019
Last update
Jan 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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