Back to resultsProtection of Ovarian Function in Female Patients With Hodgkin Lymphoma (PROFE)
Primary Purpose
Hodgkins Lymphoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
8 cycles BEACOPPesc plus oral contraceptive
8 cycles BEACOPPesc plus Goserelin
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkins Lymphoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
FSH level 6 month after end of treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014507
Brief Title
Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
Acronym
PROFE
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cologne
4. Oversight
5. Study Description
Brief Summary
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkins Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
8 cycles BEACOPPesc plus oral contraceptive
Intervention Type
Drug
Intervention Name(s)
8 cycles BEACOPPesc plus Goserelin
Primary Outcome Measure Information:
Title
FSH level 6 month after end of treatment
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20305034
Citation
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):2052-2060. doi: 10.1093/annonc/mdq066. Epub 2010 Mar 19.
Results Reference
result
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Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
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