Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis
NCT ID: NCT00654524
Last Updated: 2011-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2008-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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Women's Hospital School of Medicine Zhejiang University
Principal Investigators
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Xinmei Zhang, Prof.
Role: PRINCIPAL_INVESTIGATOR
Women's Hospital School Of Medicine Zhejiang University
Locations
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Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChiCTR-TRC-00000068
Identifier Type: -
Identifier Source: secondary_id
D8664L0001
Identifier Type: -
Identifier Source: org_study_id
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