Trial record 7 of 261 for:    Lymphoma AND (women OR woman OR female)

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
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:
Lymphoma
Contraceptive Agents, Female
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
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014