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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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02385448
Enrollment
144
Registered
2015-03-11
Start date
2015-02-28
Completion date
2019-02-28
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

dienogest, combined oral contraceptive pills, endometriosis

Brief summary

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

Interventions

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of ovarian endometrioma2 yearsTime to recurrence by sonography (months)

Secondary

MeasureTime frameDescription
Side effects2 yearsDays of irregular bleeding
Symptoms of endometriosis2 yearsPain by visual analog score
Need for additional analgesics2 yearsTypes of analgesics used

Countries

Hong Kong

Contacts

Primary ContactJennifer K.Y. Ko, MBBS, MRCOG
jenko@hku.hk852 22554647
Backup ContactMan Wa Lui, MBBS, MRCOG
luimanwa@gmail.com852 22554647

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026