Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Zhejiang University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Zhejiang University

ClinicalTrials.gov Identifier:

NCT00654524

First received: April 2, 2008

Last updated: March 14, 2011

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2008

Last Updated Date

March 14, 2011

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The recurrent rate of advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a management ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00654524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The pregnancy rate following laparoscopic surgery for advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

Official Title ^ICMJE

A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis

Brief Summary

The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

Detailed Description

In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Endometriosis

Intervention ^ICMJE

Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin

The patient will be managed with GnRH-a injection (Goserelin 3.6mg) every 4 weeks for 6 months plus add-back therapy (Caltrate With Vitamin D 600mg p.o. q.d.& Livial 1.25-2.5mg p.o. q.d.) if needed.

Other Names:

Goserelin
Caltrate With Vitamin D 600
Livial

Study Arm (s)

Experimental: 1
Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.

Intervention: Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
No Intervention: 2
The patient with advanced endometriosis（stage III-IV）confirmed histologically after conservative laparoscopic surgery will be suggested to prepare for spontaneous pregnancy rather than any medical administration.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age >=18 years old
Normal menstruation for 3 months before enrollment (25-35 days）
Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia
Agreement on the strict follow-up plan
Without previous hormonal treatment
Using nonhormonal method of contraception during this study

Exclusion Criteria:

Serious heart diseases/pulmonary/liver/kidney diseases
Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain
Suspected malignancy in endometriosis
Coagulation disorders with hemorrhagic tendency
Pregnancy or lactation
Allergy to GnRHa
Previous ineffective treatment with GnRHa

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Xinmei Zhang, Prof.

0086-571-87061501 ext 2131

zhangxinm@zju.edu.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00654524

Other Study ID Numbers ^ICMJE

D8664L0001, ChiCTR-TRC-00000068

Has Data Monitoring Committee

Yes

Responsible Party

XINMEI ZHANG, Women's Hospital School of Medicine Zhejiang University

Study Sponsor ^ICMJE

Zhejiang University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Xinmei Zhang, Prof.

Women's Hospital School Of Medicine Zhejiang University

Information Provided By

Zhejiang University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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