Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
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.
- The recurrent rate of advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a management ]
- The pregnancy rate following laparoscopic surgery for advanced endometriosis [ Time Frame: within one year after surgery or GnRH-a treatment ]
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 ClinicalTrials.gov identifier (NCT number): NCT00654524
|Contact: Xinmei Zhang, Prof.||0086-571-87061501 ext firstname.lastname@example.org|
|Women's Hospital School Of Medicine Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310006|
|Contact: Xinmei Zhang, Prof. 0086-571-87061501 ext 2131 email@example.com|
|Sub-Investigator: Xiufeng Huang, A/Prof.|
|Principal Investigator:||Xinmei Zhang, Prof.||Women's Hospital School Of Medicine Zhejiang University|