Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery
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
1 other identifier
interventional
144
1 country
1
Brief Summary
The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedApril 29, 2015
March 1, 2015
2 years
February 12, 2015
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence of ovarian endometrioma
Time to recurrence by sonography (months)
2 years
Recurrence of ovarian endometrioma
Size of recurrent endometrioma on sonography (mean diameter in centimeters)
2 years
Secondary Outcomes (3)
Side effects
2 years
Symptoms of endometriosis
2 years
Need for additional analgesics
2 years
Study Arms (2)
Dienogest
EXPERIMENTALCombined oral contraceptive pills
ACTIVE COMPARATORInterventions
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, 000000, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer K.Y. Ko, MBBS, MRCOG
The University of Hong Kong, Queen Mary Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2015
First Posted
March 11, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2019
Last Updated
April 29, 2015
Record last verified: 2015-03