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

Phase 4

• Conditions: Endometriosis
• Interventions: Drug: Dienogest; Drug: Microgynon

• Registration Number: NCT02385448
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29
• Primary Completion: 2017-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest	Dienogest	-
Combined oral contraceptive pills	Microgynon	-

Primary Outcome Measures

Name	Time	Method
Recurrence of ovarian endometrioma	2 years	Size of recurrent endometrioma on sonography (mean diameter in centimeters)

Secondary Outcome Measures

Name	Time	Method
Side effects	2 years	Days of irregular bleeding
Need for additional analgesics	2 years	Types of analgesics used
Symptoms of endometriosis	2 years	Pain by visual analog score

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong