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Sponsored by: |
Mahidol University |
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Information provided by: | Mahidol University |
ClinicalTrials.gov Identifier: | NCT00455845 |
this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only
Condition | Intervention | Phase |
---|---|---|
Endometriosis Pelvic Pain Dysmenorrhea |
Device: Levonorgestrel IUD |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind Randomized Controlled Trial to Study the Effectiveness of a Levonorgestrel Releasing Intrauterine Device for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis |
Estimated Enrollment: | 54 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 levonorgestrel IUD: Active Comparator |
Device: Levonorgestrel IUD
levonorgestrel IUD
|
2 control: No Intervention |
Device: Levonorgestrel IUD
levonorgestrel IUD
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Endometriosis is a common cause of chronic pelvic pain.Laparoscopic surgery is often the treatment of choice for symptomatic disease and results are usually satisfactory but symptoms recur in 10-20% of treated women per year.
Postoperative medical therapy has been controversial. Whereas some studies have observed a long pain free interval or higher pregnancy rates when surgical treatment is followed by an interval of medical suppressive treatment, numerous others have found no differences between the prevalence of recurrent pain or pregnancy rates 1-3 years after surgery treatment in women who did and did not receive postoperative medical treatment.Endometriosis is generally a localized disease but is currently managed with systemic medical therapies. The use of drugs administered locally and specifically aimed at pelvic organs could limit the metabolic impact without reducing antalgic efficacy.An intrauterine device releasing levonorgestrel, a potent 19-nortestosterone derivative progestin, can induce amenorrhea with a different modality with respect to standard regimens. The levonorgestrel intrauterine device (Lng-IUD) provides an alternative means of administering progestins.Some researchers reported the effectiveness of the Lng IUD in the patients with endometriosis.The primary objective of this study is to determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only. The secondary objective is to compare about pain, bleeding, satisfaction and quality of life score between both groups
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Prasong Tanmahasamut, M.D. | 6624197000 ext 4657 | prasong98@gmail.com |
Contact: Manee Rattanachaiyanont, M.D. | 6624197000 ext 4657 | sirmt@mahidol.ac.th |
Thailand, Bangkok | |
Mahidol University | Recruiting |
Bangkoknoi, Bangkok, Thailand, 10700 | |
Contact: Prasong Tanmahasamut, Doctor 6624197000 ext 4657 prasong98@gmail.com | |
Contact: Manee Rattanachaiyanont, Doctor 6624197000 ext 4657 simrt@mahidol.ac.th |
Principal Investigator: | Prasong Tanmahasamut, M.D. | Mahidol University |
Responsible Party: | Mahidol University ( Associate Prof. Prasong Tanmahasamut ) |
Study ID Numbers: | 15/2007 |
Study First Received: | April 3, 2007 |
Last Updated: | April 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00455845 History of Changes |
Health Authority: | Thailand: Ministry of Public Health |
Endometriosis Lng IUD |
Genital Diseases, Female Signs and Symptoms Pelvic Pain Menstruation Disturbances Dysmenorrhea Contraceptive Agents |
Levonorgestrel Contraceptives, Oral Contraceptive Agents, Female Endometriosis Pain |
Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Endometriosis Pain Reproductive Control Agents Pharmacologic Actions Genital Diseases, Female |
Signs and Symptoms Pelvic Pain Pathologic Processes Dysmenorrhea Menstruation Disturbances Therapeutic Uses Levonorgestrel Contraceptives, Oral, Synthetic |