NCT01014507

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
Last Updated

June 25, 2012

Status Verified

October 1, 2011

Enrollment Period

5.7 years

First QC Date

November 16, 2009

Last Update Submit

June 22, 2012

Conditions

Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (1)

  • FSH level 6 month after end of treatment

    6 month

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: 8 cycles BEACOPPesc plus oral contraceptive

B

EXPERIMENTAL
Drug: 8 cycles BEACOPPesc plus Goserelin

Interventions

8 cycles BEACOPPesc plus oral contraceptiveDRUG
A
8 cycles BEACOPPesc plus GoserelinDRUG
B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20305034RESULT

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Contraceptives, OralGoserelin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

January 1, 2004

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 25, 2012

Record last verified: 2011-10