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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

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ClinicalTrials.gov Identifier: NCT02385448
Recruitment Status : Unknown
Verified March 2015 by The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : March 11, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Dienogest Drug: Microgynon Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Dienogest

Arm Intervention/treatment
Experimental: Dienogest Drug: Dienogest
The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
Other Name: Visanne

Active Comparator: Combined oral contraceptive pills Drug: Microgynon
The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.




Primary Outcome Measures :
  1. Recurrence of ovarian endometrioma [ Time Frame: 2 years ]
    Time to recurrence by sonography (months)

  2. Recurrence of ovarian endometrioma [ Time Frame: 2 years ]
    Size of recurrent endometrioma on sonography (mean diameter in centimeters)


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 2 years ]
    Days of irregular bleeding

  2. Symptoms of endometriosis [ Time Frame: 2 years ]
    Pain by visual analog score

  3. Need for additional analgesics [ Time Frame: 2 years ]
    Types of analgesics used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385448


Contacts
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Contact: Jennifer K.Y. Ko, MBBS, MRCOG 852 22554647 jenko@hku.hk
Contact: Man Wa Lui, MBBS, MRCOG 852 22554647 luimanwa@gmail.com

Locations
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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, 000000
Contact: Jennifer K.Y. Ko, MBBS, MRCOG    22554647    jenko@hku.hk   
Contact: Ellen Lui, MBBS, MRCOG    22554647    luimanwa@gmail.com   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Jennifer K.Y. Ko, MBBS, MRCOG The University of Hong Kong, Queen Mary Hospital

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02385448     History of Changes
Other Study ID Numbers: UW 14-097
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: March 2015

Keywords provided by The University of Hong Kong:
dienogest
combined oral contraceptive pills
endometriosis

Additional relevant MeSH terms:
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Recurrence
Endometriosis
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Contraceptive Agents
Dienogest
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Nandrolone
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Hormones
Anabolic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital