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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385448
• Other study ID #: UW 14-097
• Status: Recruiting
• Phase: Phase 4
• First received: February 12, 2015
• Last updated: April 28, 2015
• Start date: February 2015
• Est. completion date: February 2019

Study information

• Verified date: March 2015
• Source: The University of Hong Kong
• Contact: Jennifer K.Y. Ko, MBBS, MRCOG
• Phone: 852 22554647
• Email: jenko[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: February 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Dienogest
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
• Microgynon
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of ovarian endometrioma	Time to recurrence by sonography (months)	2 years	No
Primary	Recurrence of ovarian endometrioma	Size of recurrent endometrioma on sonography (mean diameter in centimeters)	2 years
Secondary	Side effects	Days of irregular bleeding	2 years	No
Secondary	Symptoms of endometriosis	Pain by visual analog score	2 years	No
Secondary	Need for additional analgesics	Types of analgesics used	2 years	No