Dydrogesterone in the Treatment of Endometrial Polyps

NCT03790215 | Completed Phase 4

• 1 other identifier: EP-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Polyp

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Side effects

  three months after the starting of treatment

Study Arms (1)

cohort for treatment

EXPERIMENTAL

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

Dydrogesterone DRUG

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

cohort for treatment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Interventions

Dydrogesterone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 31, 2018
• Study Start: February 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)