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Completed

NCT Number: NCT01014507

Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

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

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Key information

Conditions

Hodgkins Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8 cycles BEACOPPesc plus oral contraceptive

Drug

8 cycles BEACOPPesc plus Goserelin

Drug

Primary outcomes

  1. FSH level 6 month after end of treatment

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study 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

Acronym: PROFE

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2009
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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