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

This study has been completed.
Information provided by:
University of Cologne Identifier:
First received: November 16, 2009
Last updated: June 22, 2012
Last verified: October 2011
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
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

Resource links provided by NLM:

Further study details as provided by University of Cologne:

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

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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: German Hodgkin Study Group Identifier: NCT01014507     History of Changes
Other Study ID Numbers: PROFE
Study First Received: November 16, 2009
Last Updated: June 22, 2012

Additional relevant MeSH terms:
Contraceptive Agents, Female
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on August 21, 2017