Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
This study is designed to test the the protective capacity of Goserelin compared with oral...
Brief Summary
Official Title: “Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien”
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- Drug: 8 cycles BEACOPPesc plus oral contraceptive
- Drug: 8 cycles BEACOPPesc plus Goserelin
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: A
- Experimental: B
Outcome Measures for this Clinical Trial
Primary Measures
- FSH level 6 month after end of treatment
- Time Frame: 6 month
Safety Issue?: No
- Time Frame: 6 month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Advanced stage Hodgkins Lymphoma (histologically proven)
- Normal FSH-levels
- Written informed consent
Exclusion Criteria:
- Hodgkins Lymphoma as "composite lymphoma"
- Primary ovarial dysfunction
- Age > 40
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Cologne Other
Related Publications
Citations Reporting Results
Behringer K, Wildt L, Mueller H, Mattle V, Ganitis P, van den Hoonaard B, Ott HW, Hofer S, Pluetschow A, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group. Ann Oncol. 2010 Oct;21(10):2052-60. Epub 2010 Mar 19.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01014507
Study ID Number: PROFE
ClinicalTrials.gov Identifier: NCT01014507
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01014507
