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

This study has been completed.

Sponsor:

Information provided by:

University of Cologne

ClinicalTrials.gov Identifier:

NCT01014507

First received: November 16, 2009

Last updated: June 22, 2012

Last verified: October 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Hodgkins Lymphoma	Drug: 8 cycles BEACOPPesc plus oral contraceptive Drug: 8 cycles BEACOPPesc plus Goserelin	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Goserelin Goserelin acetate

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

FSH level 6 month after end of treatment [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	January 2004
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: 8 cycles BEACOPPesc plus oral contraceptive
Experimental: B	Drug: 8 cycles BEACOPPesc plus Goserelin

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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):2052-60. Epub 2010 Mar 19.

Responsible Party:	German Hodgkin Study Group
ClinicalTrials.gov Identifier:	NCT01014507 History of Changes
Other Study ID Numbers:	PROFE
Study First Received:	November 16, 2009
Last Updated:	June 22, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Contraceptive Agents

Contraceptives, Oral
Goserelin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013

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