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Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

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ClinicalTrials.gov Identifier: NCT01092494
Recruitment Status : Unknown
Verified March 2010 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:

Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions, and conservative laparoscopic surgery is the treatment of choice. However, the recurrence after surgery is common.

As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after surgery frustrates both patients and clinicians. In this aspect, medical treatments have been offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is rather controversial. On the other hand, it has been demonstrated that oral contraceptives (OCs) could reduce or delay endometrioma recurrence, but data are still limited. Consequently, no one type of postoperative medical therapy has been shown to be superior in reducing the recurrence of endometrioma.

The rationale of postoperative medical therapy is that it could eradicate microscopic lesions which were not found and not treated sufficiently during surgery. Therefore, the maintenance of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs could be a promising treatment to prevent the recurrence, but it has not been widely investigated.

We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of endometrioma recurrence.


Condition or disease
Endometriosis

Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence
Study Start Date : March 2010
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
OC use
OC use after postoperative gonadotropin-releasing hormone agonist treatment
OC non-use
Only postoperative gonadotropin-releasing hormone agonist treatment



Primary Outcome Measures :
  1. recurrence rate of endometrioma [ Time Frame: 60 months ]


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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Reproductive aged women who underwent conservative laparoscopic surgery for ovarian endometrioma and followed up at Samsung Medical Center between January 2000 and December 2007.
Criteria

Inclusion Criteria:

  1. reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
  2. women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
  3. women with no residual lesion confirmed by ultrasonography after surgery
  4. women who were followed up for over 12 months after surgery.

Exclusion Criteria:if they had

  1. undergone hysterectomy during an operation
  2. been given GnRHa injections more than 6 times
  3. been given other types of postoperative treatment (progestin or intrauterine device)
  4. a history of previous pelvic surgery for endometriosis
  5. a history of hormonal treatment before surgery
  6. been diagnosed as menopause after surgery
  7. contraindications to OCs
  8. been identified ovarian endometriomas within 6 months of postoperative evaluation

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): NCT01092494


Contacts
Contact: DooSeok Choi, MD, PhD 82-2-3410-3514 dooseok.choi@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: DooSeok Choi       dooseok.choi@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: DooSeok Choi Samsung Medical Center

Publications:
Responsible Party: DooSeok Choi, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092494     History of Changes
Other Study ID Numbers: 2010-02-020
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Samsung Medical Center:
Endometrioma recurrence
oral contraceptives
gonadotropin-releasing hormone agonist

Additional relevant MeSH terms:
Recurrence
Endometriosis
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Hormones
Contraceptive Agents
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female