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

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02385448
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Dienogest; Drug: Microgynon	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: Feb 1, 2015
• Anticipated Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dienogest	Drug: Dienogest; The dienogest group will receive dienogest 2mg daily for 24 months postoperatively; Other Names: Visanne
Active Comparator: Combined oral contraceptive pills	Drug: Microgynon; The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.

Outcome Measures

Primary Outcome Measures

1. Recurrence of ovarian endometrioma [2 years]

   Time to recurrence by sonography (months)

2. Recurrence of ovarian endometrioma [2 years]

   Size of recurrent endometrioma on sonography (mean diameter in centimeters)

Secondary Outcome Measures

1. Side effects [2 years]

   Days of irregular bleeding

2. Symptoms of endometriosis [2 years]

   Pain by visual analog score

3. Need for additional analgesics [2 years]

   Types of analgesics used

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 51 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		Hong Kong	000000

Sponsors and Collaborators

• The University of Hong Kong

Investigators

• Principal Investigator: Jennifer K.Y. Ko, MBBS, MRCOG, The University of Hong Kong, Queen Mary Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT02385448
• Other Study ID Numbers: UW 14-097
• First Posted: Mar 11, 2015
• Last Update Posted: Apr 29, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by The University of Hong Kong: dienogest; combined oral contraceptive pills; endometriosis
• Additional relevant MeSH terms: Endometriosis; Recurrence; Dienogest; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination

Study Results

No Results Posted as of Apr 29, 2015