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
  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:


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
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

Publications:
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Contraceptive Agents
Contraceptives, Oral
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014