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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Primary Measures

• FSH level 6 month after end of treatment
  • Time Frame: 6 month
    Safety Issue?: No

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

Lead Sponsor: University of Cologne

Information obtained from ClinicalTrials.gov on February 04, 2010

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