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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654524
Recruitment Status : Unknown
Verified September 2008 by Zhejiang University.
Recruitment status was:  Recruiting
First Posted : April 8, 2008
Last Update Posted : March 15, 2011
Information provided by:
Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
Study Start Date : March 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

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.

Primary Outcome Measures :
  1. The recurrent rate of advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a management ]

Secondary Outcome Measures :
  1. The pregnancy rate following laparoscopic surgery for advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654524

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Contact: Xinmei Zhang, Prof. 0086-571-87061501 ext 2131

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China, Zhejiang
Women's Hospital School Of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Xinmei Zhang, Prof.    0086-571-87061501 ext 2131   
Sub-Investigator: Xiufeng Huang, A/Prof.         
Sponsors and Collaborators
Zhejiang University
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Principal Investigator: Xinmei Zhang, Prof. Women's Hospital School Of Medicine Zhejiang University

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Responsible Party: XINMEI ZHANG, Women's Hospital School of Medicine Zhejiang University Identifier: NCT00654524     History of Changes
Other Study ID Numbers: D8664L0001
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: September 2008

Keywords provided by Zhejiang University:
Pregnancy Rate
Gonadotropin-Releasing Hormone

Additional relevant MeSH terms:
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Genital Diseases, Female
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents