PROFE: Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01014507
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 68

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkins Lymphoma	Drug: 8 cycles BEACOPPesc plus oral contraceptive; Drug: 8 cycles BEACOPPesc plus Goserelin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• 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
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: 8 cycles BEACOPPesc plus oral contraceptive
Experimental: B	Drug: 8 cycles BEACOPPesc plus Goserelin

Outcome Measures

Primary Outcome Measures

1. FSH level 6 month after end of treatment [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• 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

Locations

No locations specified.

Sponsors and Collaborators

• University of Cologne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01014507
• Other Study ID Numbers: PROFE
• First Posted: Nov 17, 2009
• Last Update Posted: Jun 25, 2012
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Goserelin; Contraceptive Agents; Contraceptives, Oral

Study Results

No Results Posted as of Jun 25, 2012