EndometriosisPhase 4NCT02385448
Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery
A Phase 4 study testing Dienogest and Microgynon in people with Endometriosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest and Microgynon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2015to Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 000000
Jennifer K.Y. Ko, MBBS, MRCOG, 22554647, jenko@hku.hk
Ellen Lui, MBBS, MRCOG, 22554647, luimanwa@gmail.com
About this study
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
The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.
- Conditions
- Endometriosis
- Being tested
- Dienogest, Microgynon
- Keywords
- dienogest, combined oral contraceptive pills, endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Also called Visanne
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
MicrogynonDrug
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Experimental | Not described Receives: Drug: Dienogest |
| Combined oral contraceptive pills | Active comparator | Not described Receives: Drug: Microgynon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of ovarian endometrioma
Time to recurrence by sonography (months)
Measured: 2 years
Recurrence of ovarian endometrioma
Size of recurrent endometrioma on sonography (mean diameter in centimeters)
Measured: 2 years
Secondary outcomes (3)
Side effects
Days of irregular bleeding
Measured: 2 years
Symptoms of endometriosis
Pain by visual analog score
Measured: 2 years
Need for additional analgesics
Types of analgesics used
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer K.Y. Ko, MBBS, MRCOG, Principal investigator, The University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385448
- Sponsor's protocol ID
- UW 14-097
- Status last verified
- Mar 2015
- First submitted
- 12 Feb 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02385448
- Acronym / sponsor ID
- UW 14-097
- Conditions
- Endometriosis
- Keywords
- dienogest, combined oral contraceptive pills, endometriosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Experimental | Drug: Dienogest |
| Combined oral contraceptive pills | Active comparator | Drug: Microgynon |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DienogestAlso: VisanneThe dienogest group will receive dienogest 2mg daily for 24 months postoperatively | Drug | Dienogest |
| MicrogynonThe combined oral contraceptive pills group will be given cyclical Microgynon for 24 months. | Drug | Combined oral contraceptive pills |
Primary outcome
Recurrence of ovarian endometrioma
Time frame: 2 years
Time to recurrence by sonography (months)
Recurrence of ovarian endometrioma
Time frame: 2 years
Size of recurrent endometrioma on sonography (mean diameter in centimeters)
3 secondary outcomes
Side effects
Time frame: 2 years
Symptoms of endometriosis
Time frame: 2 years
Need for additional analgesics
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K.Y. Ko, MBBS, MRCOG principal investigator
The University of Hong Kong, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dienogest and Microgynon in people with Endometriosis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer K.Y. Ko, MBBS, MRCOG (852 22554647, jenko@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of ovarian endometrioma (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.