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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01125488
First received: April 26, 2010
Last updated: June 6, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Endometriosis
Device: LNG-IUS
Drug: GnRH agonist (triptorelin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maintenance Therapy of LNG-IUS in Conjunction With the GnRH Agonist to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery: A Prospective Randomized, Phase III Trial

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Recurrence rate of endometriosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will follow the patients for 2 years, after the end of GnRH agonist medical treatment. Number of Participants with recurrence as a Measure of the clinical efficacy of LNG-IUS maintenance therapy to prevent recurrence of endometriosis.


Secondary Outcome Measures:
  • the safety of LNG-IUS maintenance therapy to prevent recurrence of endometriosis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability.


Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG-IUS
LNG-IUS insertion during conservative surgery and GnRH agonist 6 doses.
Device: LNG-IUS
levonorgestrel-releasing intrauterine system (LNG-IUS) 52mg, duration 5 years
Other Name: mirena
Drug: GnRH agonist (triptorelin)
GnRH agonist (triptorelin 3.75 mg, sc q28day)
Active Comparator: GnRH agonist
The second group of patients receive GnRH agonist (triptorelin 3.75 mg, sc q28day) alone for 24 weeks.
Drug: GnRH agonist (triptorelin)
GnRH agonist (triptorelin 3.75 mg, sc q28day)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125488

Contacts
Contact: Yi-Jen Chen, MD 886-2-28757566 chenyj@vghtpe.gov.tw
Contact: PH Wang, MD, PhD 886-2-28757566 phwang@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans Genreal Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Yi-Jen Chen, MD. PhD    886 22 8757566    chenyj@vghtpe.gov.tw   
Principal Investigator: Yi-Jen Chen, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Yi-Jen Chen, MD Department OBS & GYN, Taipei Veterans General Hospital
  More Information

No publications provided

Responsible Party: Yi-Jen Chen MD, Department of Obstetrics & Gynecology,Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01125488     History of Changes
Other Study ID Numbers: VGHIRB 97-04-03
Study First Received: April 26, 2010
Last Updated: June 6, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Maintenance therapy
LNG-IUS
recurrence,endometriosis
Recurrence

Additional relevant MeSH terms:
Endometriosis
Recurrence
Disease Attributes
Genital Diseases, Female
Pathologic Processes
Deslorelin
Levonorgestrel
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Enzyme Inhibitors
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014