Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

Endometriosis Clinical Trial

Official title:

Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01092494
• Other study ID #: 2010-02-020
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2010
• Last updated: March 24, 2010
• Start date: March 2010
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Samsung Medical Center
• Contact: DooSeok Choi, MD, PhD
• Phone: 82-2-3410-3514
• Email: dooseok.choi[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometriosis
• Recurrence

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Park HJ, Koo YA, Yoon BK, Choi D. Postoperative long-term maintenance therapy with oral contraceptives after gonadotropin-releasing hormone analog treatment in women with ovarian endometrioma. J Minim Invasive Gynecol. 2009 Jan-Feb;16(1):34-9. doi: 10.1016/j.jmig.2008.09.582. Epub 2008 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate of endometrioma		60 months	No