Dydrogesterone in the Treatment of Endometrial Polyps

Prospective One-arm Cohort Study of 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.

Study Overview

• Status: Completed
• Conditions: Endometrial Polyp
• Intervention / Treatment: Drug: Dydrogesterone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	three months after the starting of treatment
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	six months after the starting of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Any side effects during the treatment	three months after the starting of treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Polyps; Uterine Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: EP-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No