Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

April 28, 2015 updated by: The University of Hong Kong

A Prospective, Randomized Controlled Trial Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Jennifer K.Y. Ko, MBBS, MRCOG
          • Phone Number: 22554647
          • Email: jenko@hku.hk
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Good general health
  • Older than the age of legal consent (i.e. 18 years old)
  • Sonographic diagnosis of ovarian endometrioma with diameter at least 4cm on 2 separate scans at least 6 weeks apart
  • No contraindication to use of progesterone or combined oral contraceptive pills
  • Not attempting to conceive either at the time of study entry or for at least 2 years after surgery
  • Willing and able to participate after the study has been explained

Exclusion Criteria:

  • Operative findings not suggestive of endometriotic cyst
  • Contraindications to progestogens or oral contraceptive pills
  • Unwillingness to tolerate menstrual irregularity
  • Planning pregnancy within 2 years of study
  • Cannot understand English, Cantonese or Putonghua

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dienogest
Drug: Dienogest
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
Other Names:
  • Visanne
Active Comparator: Combined oral contraceptive pills
Drug: Microgynon
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of ovarian endometrioma
Time Frame: 2 years
Time to recurrence by sonography (months)
2 years
Recurrence of ovarian endometrioma
Time Frame: 2 years
Size of recurrent endometrioma on sonography (mean diameter in centimeters)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 2 years
Days of irregular bleeding
2 years
Symptoms of endometriosis
Time Frame: 2 years
Pain by visual analog score
2 years
Need for additional analgesics
Time Frame: 2 years
Types of analgesics used
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Jennifer K.Y. Ko, MBBS, MRCOG, The University of Hong Kong, Queen Mary Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 14-097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Dienogest

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe