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

NCT01125488 | Unknown Phase 3 DMC

• 1 other identifier: VGHIRB 97-04-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

Maintenance therapy; LNG-IUS; recurrence,endometriosis; Recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of endometriosis

  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.

  2 years

Secondary Outcomes (1)

• the safety of LNG-IUS maintenance therapy to prevent recurrence of endometriosis.

  2 years

Study Arms (2)

LNG-IUS

EXPERIMENTAL

LNG-IUS insertion during conservative surgery and GnRH agonist 6 doses.

Device: LNG-IUS; Drug: GnRH agonist (triptorelin)

GnRH agonist

ACTIVE COMPARATOR

The second group of patients receive GnRH agonist (triptorelin 3.75 mg, sc q28day) alone for 24 weeks.

Drug: GnRH agonist (triptorelin)

Interventions

LNG-IUS DEVICE

levonorgestrel-releasing intrauterine system (LNG-IUS) 52mg, duration 5 years

Also known as: mirena

LNG-IUS

GnRH agonist (triptorelin) DRUG

GnRH agonist (triptorelin 3.75 mg, sc q28day)

GnRH agonist; LNG-IUS

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans Genreal Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Endometriosis; Recurrence

Interventions

Gonadotropin-Releasing Hormone; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Yi-Jen Chen, MD

  Department OBS & GYN, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Jen Chen, MD

CONTACT

886-2-28757566; chenyj@vghtpe.gov.tw

PH Wang, MD, PhD

CONTACT

886-2-28757566; phwang@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 18, 2010
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2010-06

Locations

TW (1)