Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

Hodgkins Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014507
• Other study ID #: PROFE
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2009
• Last updated: June 22, 2012
• Start date: January 2004
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkins Lymphoma

Intervention

Drug:
• 8 cycles BEACOPPesc plus oral contraceptive

• 8 cycles BEACOPPesc plus Goserelin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

References & Publications (1)

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 contrace — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSH level 6 month after end of treatment		6 month	No