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

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ClinicalTrials.gov Identifier: NCT01014507
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : June 25, 2012
Sponsor:
Information provided by:
University of Cologne

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

Condition or disease Intervention/treatment Phase
Hodgkins Lymphoma Drug: 8 cycles BEACOPPesc plus oral contraceptive Drug: 8 cycles BEACOPPesc plus Goserelin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Goserelin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: 8 cycles BEACOPPesc plus oral contraceptive
Experimental: B Drug: 8 cycles BEACOPPesc plus Goserelin



Primary Outcome Measures :
  1. FSH level 6 month after end of treatment [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Publications of Results:
Responsible Party: German Hodgkin Study Group
ClinicalTrials.gov Identifier: NCT01014507     History of Changes
Other Study ID Numbers: PROFE
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: October 2011

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
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
Contraceptive Agents, Female
Antineoplastic Agents, Hormonal
Antineoplastic Agents