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Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01014507
Acronym
PROFE
Enrollment
60
Registered
2009-11-17
Start date
2004-01-31
Completion date
2009-09-30
Last updated
2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkins Lymphoma

Brief summary

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

Interventions

DRUG8 cycles BEACOPPesc plus oral contraceptive
DRUG8 cycles BEACOPPesc plus Goserelin

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frame
FSH level 6 month after end of treatment6 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026