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