EndometriosisNCT01092494
Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence
An observational study of Endometriosis, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 232 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
- women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
- women with no residual lesion confirmed by ultrasonography after surgery
- women who were followed up for over 12 months after surgery.
Who cannot join
- undergone hysterectomy during an operation
- been given GnRHa injections more than 6 times
- been given other types of postoperative treatment (progestin or intrauterine device)
- a history of previous pelvic surgery for endometriosis
- a history of hormonal treatment before surgery
- been diagnosed as menopause after surgery
- contraindications to OCs
- been identified ovarian endometriomas within 6 months of postoperative evaluation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Seoul, 135-710
DooSeok Choi, dooseok.choi@samsung.com
About this study
Official title: Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence
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.
Read more
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.
- Conditions
- Endometriosis
- Keywords
- Endometrioma recurrence, oral contraceptives, gonadotropin-releasing hormone agonist
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OC use | OC use after postoperative gonadotropin-releasing hormone agonist treatment | |
| OC non-use | Only postoperative gonadotropin-releasing hormone agonist treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of endometrioma
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- DooSeok Choi, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092494
- Sponsor's protocol ID
- 2010-02-020
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18976968
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence
- ClinicalTrials.gov ID
- NCT01092494
- Acronym / sponsor ID
- 2010-02-020
- Conditions
- Endometriosis
- Keywords
- Endometrioma recurrence, oral contraceptives, gonadotropin-releasing hormone agonist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC use | – | –OC use after postoperative gonadotropin-releasing hormone agonist treatment |
| OC non-use | – | –Only postoperative gonadotropin-releasing hormone agonist treatment |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
- women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
- women with no residual lesion confirmed by ultrasonography after surgery
- women who were followed up for over 12 months after surgery.
Key exclusion criteria (8 listed)
- undergone hysterectomy during an operation
- been given GnRHa injections more than 6 times
- been given other types of postoperative treatment (progestin or intrauterine device)
- a history of previous pelvic surgery for endometriosis
- a history of hormonal treatment before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
recurrence rate of endometrioma
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
- Background: PubMed 18976968Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DooSeok Choi study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DooSeok Choi, MD, PhD (82-2-3410-3514, dooseok.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of endometrioma (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.