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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
  Purpose

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 Intervention Phase
Endometriosis
 Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654524

Contacts
Contact: Xinmei Zhang, Prof. 0086-571-87061501 ext 2131 zhangxinm@zju.edu.cn

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

No publications provided

Responsible Party: XINMEI ZHANG, Women's Hospital School of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT00654524     History of Changes
Other Study ID Numbers: D8664L0001, ChiCTR-TRC-00000068
Study First Received: April 2, 2008
Last Updated: March 14, 2011
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Vitamin D
Vitamins
Hormones
Goserelin
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Micronutrients
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013