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

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Dienogest
Microgynon
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometriosis focused on measuring dienogest, combined oral contraceptive pills, endometriosis

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dienogest

Combined oral contraceptive pills

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of ovarian endometrioma
Time to recurrence by sonography (months)
Recurrence of ovarian endometrioma
Size of recurrent endometrioma on sonography (mean diameter in centimeters)

Secondary Outcome Measures

Side effects
Days of irregular bleeding
Symptoms of endometriosis
Pain by visual analog score
Need for additional analgesics
Types of analgesics used

Full Information

First Posted
February 12, 2015
Last Updated
April 28, 2015
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02385448
Brief Title
Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
dienogest, combined oral contraceptive pills, endometriosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dienogest
Arm Type
Experimental
Arm Title
Combined oral contraceptive pills
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dienogest
Other Intervention Name(s)
Visanne
Intervention Description
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
Intervention Type
Drug
Intervention Name(s)
Microgynon
Intervention Description
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.
Primary Outcome Measure Information:
Title
Recurrence of ovarian endometrioma
Description
Time to recurrence by sonography (months)
Time Frame
2 years
Title
Recurrence of ovarian endometrioma
Description
Size of recurrent endometrioma on sonography (mean diameter in centimeters)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Side effects
Description
Days of irregular bleeding
Time Frame
2 years
Title
Symptoms of endometriosis
Description
Pain by visual analog score
Time Frame
2 years
Title
Need for additional analgesics
Description
Types of analgesics used
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer K.Y. Ko, MBBS, MRCOG
Phone
852 22554647
Email
jenko@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Man Wa Lui, MBBS, MRCOG
Phone
852 22554647
Email
luimanwa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer K.Y. Ko, MBBS, MRCOG
Organizational Affiliation
The University of Hong Kong, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer K.Y. Ko, MBBS, MRCOG
Phone
22554647
Email
jenko@hku.hk
First Name & Middle Initial & Last Name & Degree
Ellen Lui, MBBS, MRCOG
Phone
22554647
Email
luimanwa@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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