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Completed

NCT Number: NCT03790215

Dydrogesterone in the Treatment of Endometrial Polyps

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

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dydrogesterone

Drug

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

Primary outcomes

  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 outcomes

  1. Side effects

    Time frame: three months after the starting of treatment

    Any side effects during the treatment

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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