Maintenance Therapy of Levonorgestrel-releasing Intrauterine System (LNG-IUS) to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The recurrence rates of endometriosis reported in women 5 years after therapy with gonadotropin releasing hormone (GnRH) agonist were 74% for severe disease . No strategies to prevent the recurrence of endometriosis have been uniformly successful. Local progesterone treatment of endometriosis-associated dysmenorrhea with a levonorgestrel-releasing intrauterine system (LNG-IUS) for 12 months has resulted in a significant reduction in dysmenorrhea, pelvic pain and dyspareunia; a high degree of patient satisfaction; and a significant reduction in the volume of rectovaginal endometriotic nodules. LNG-IUS may become a more important option if a long-term medical suppression of endometriosis.

Based on literature review, I hypothesized that maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates endometriosis after conservative surgery. We try to answer the question whether maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates and thus extend the symptom-free interval (menorrhagia and dysmenorrhea) as compared to GnRH agonist alone after conservative surgery in severe endometriosis cases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Deslorelin; Levonorgestrel; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• Patients with moderate-severe symptomatic endometriosis (rASRM score >16) according to the American Society for Reproductive Medicine) or adenomyosis. Symptomatic endometriosis means menorrhagia or dysmenorrhea.

• All patients were surgically treated by a conservative approach.

• Levels of serum CA125 is higher than normal range.

Exclusion Criteria:

• Further desire for child bearing in future 3 years.

• Any treatment for endometriosis within the previous 2 months.

• Any concomitant disease that can be an established cause of chronic pelvic pain and anemia (Thalassemia anemia, inflammation sequela, myoma , and pelvic congestion etc)