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

NCT ID: NCT02385448

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-02-28

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dienogest

Group Type EXPERIMENTAL

Dienogest

Intervention Type DRUG

The dienogest group will receive dienogest 2mg daily for 24 months postoperatively

Combined oral contraceptive pills

Group Type ACTIVE_COMPARATOR

Microgynon

Intervention Type DRUG

The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.

Interventions

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Dienogest

The dienogest group will receive dienogest 2mg daily for 24 months postoperatively

Intervention Type DRUG

Microgynon

The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.

Intervention Type DRUG

Other Intervention Names

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Visanne

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer K.Y. Ko, MBBS, MRCOG

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong, Queen Mary Hospital

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Jennifer K.Y. Ko, MBBS, MRCOG

Role: CONTACT

852 22554647

Man Wa Lui, MBBS, MRCOG

Role: CONTACT

852 22554647

Facility Contacts

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Jennifer K.Y. Ko, MBBS, MRCOG

Role: primary

Ellen Lui, MBBS, MRCOG

Role: backup

Other Identifiers

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UW 14-097

Identifier Type: -

Identifier Source: org_study_id

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