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CompletedNCT01014507PROFEUpdated Jun 25, 2012

Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

A Phase 2 interventional study of 8 cycles BEACOPPesc plus oral contraceptive and 8 cycles BEACOPPesc plus Goserelin in Hodgkins Lymphoma, sponsored by University of Cologne. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-06-25.

Sponsored by University of Cologne · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Hodgkins Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Advanced stage Hodgkins Lymphoma (histologically proven)
  • Normal FSH-levels
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Hodgkins Lymphoma as "composite lymphoma"
  • Primary ovarial dysfunction
  • Age > 40
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    A

    Drug: 8 cycles BEACOPPesc plus oral contraceptive

  • Experimental
    B

    Drug: 8 cycles BEACOPPesc plus Goserelin

Interventions

  • Drug8 cycles BEACOPPesc plus oral contraceptive
  • Drug8 cycles BEACOPPesc plus Goserelin
06

What researchers measure

Primary outcomes

  1. FSH level 6 month after end of treatment

    Time frame: 6 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Behringer K, Wildt L, Mueller H, Mattle V, Ganitis P, van den Hoonaard B, Ott HW, Hofer S, Pluetschow A, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group. Ann Oncol. 2010 Oct;21(10):2052-2060. doi: 10.1093/annonc/mdq066. Epub 2010 Mar 19. PubMed 20305034 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01014507
Lead sponsor
University of Cologne
First posted
Nov 17, 2009
Start date
Jan 2004
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jun 25, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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