Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma (PROFE)

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Hodgkins Lymphoma

Treatments: Drug: 8 cycles BEACOPPesc plus Goserelin; Drug: 8 cycles BEACOPPesc plus oral contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT01014507

PROFE

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: 8 cycles BEACOPPesc plus oral contraceptive

B

Experimental group

Treatment:

Drug: 8 cycles BEACOPPesc plus Goserelin