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

June 22, 2012 updated by: University of Cologne

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Drug: 8 cycles BEACOPPesc plus oral contraceptive
EXPERIMENTAL: B
Drug: 8 cycles BEACOPPesc plus Goserelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FSH level 6 month after end of treatment
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (ESTIMATE)

November 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hodgkins Lymphoma

Clinical Trials on 8 cycles BEACOPPesc plus oral contraceptive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe