Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
NCT ID: NCT01656161
Last Updated: 2015-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2012-07-31
2013-08-31
Brief Summary
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* achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and
* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Triptorelin embonate 22.5 mg
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
Triptorelin embonate 22.5 mg
Interventions
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Triptorelin embonate 22.5 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
MALE
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Eija Lundstrom, MD
Role: STUDY_DIRECTOR
Debiopharm SA
J. Bahlmann, MD
Role: PRINCIPAL_INVESTIGATOR
Private Practitioner
Locations
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Paarl Medical Centre
Paarl, Cape Town, Western Cape, South Africa
Vergelegen Medi-Clinic
Somerset West, Cape Town, South Africa
Department of Urology, Tygerberg Hospital
Tygerberg, Cape Town, South Africa
JCM Bahlmann
George, Eastern Cape, South Africa
East Rand Urology Research Unit, Clinix Private Clinic
Johannesburg, Gautang, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, South Africa
Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
Pretoria, Gauteng, South Africa
Pretoria Urology Hospital
Pretoria, Gauteng, South Africa
Wilmed Park Hospital
Klerksdorp, North West, South Africa
New Groote Schuur Hospital, Division of Urology
Cape Town, , South Africa
Countries
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References
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Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.
Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.
Related Links
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Company website
Other Identifiers
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KRA75538
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 8206-SC-301
Identifier Type: -
Identifier Source: org_study_id
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