Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

NCT ID: NCT01014507

Last Updated: 2012-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Hodgkins Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

8 cycles BEACOPPesc plus oral contraceptive

Intervention Type DRUG

B

Group Type EXPERIMENTAL

8 cycles BEACOPPesc plus Goserelin

Intervention Type DRUG

Interventions

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8 cycles BEACOPPesc plus oral contraceptive

Intervention Type DRUG

8 cycles BEACOPPesc plus Goserelin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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German Hodgkin Study Group

References

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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.

Reference Type RESULT
PMID: 20305034 (View on PubMed)

Other Identifiers

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PROFE

Identifier Type: -

Identifier Source: org_study_id

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