Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

Phase 2

Completed

• Conditions: Hodgkins Lymphoma
• Interventions: Drug: 8 cycles BEACOPPesc plus oral contraceptive; Drug: 8 cycles BEACOPPesc plus Goserelin

• Registration Number: NCT01014507
• Lead Sponsor: University of Cologne

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2011-10
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	8 cycles BEACOPPesc plus oral contraceptive	-
B	8 cycles BEACOPPesc plus Goserelin	-

Primary Outcome Measures

Name	Time	Method
FSH level 6 month after end of treatment	6 month