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Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

NCT ID: NCT01161563

Last Updated: 2013-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

Detailed Description

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GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Conditions

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Prostate Cancer

Keywords

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palliative treatment prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Leuprolide acetate

Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.

Group Type ACTIVE_COMPARATOR

Leuprolide acetate

Intervention Type DRUG

Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Triptorelin pamoate

Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.

Group Type ACTIVE_COMPARATOR

Triptorelin pamoate

Intervention Type DRUG

Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock

Interventions

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Triptorelin pamoate

Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock

Intervention Type DRUG

Leuprolide acetate

Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;
* At least 18 years of age;
* Life expectancy of at least 1 year;
* Capable of completing the study questionnaires without assistance.

Exclusion Criteria

* Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;
* Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;
* Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide;
* History of alcohol/drug abuse within the past year;
* History of significant medical problems that may confound the outcome of this study;
* Requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain);
* Participated in another investigational drug study within 30 days
* Judged by the investigator to be unsuitable for enrollment in this study for any reason
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marilyn McIlwain, BS

Role: STUDY_DIRECTOR

Watson Pharmaceuticals, Inc.

Locations

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Watson Investigational Site

Homewood, Alabama, United States

Site Status

Watson Investigational Site

Daytona Beach, Florida, United States

Site Status

Watson Investigational Site

Orange City, Florida, United States

Site Status

Watson Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

Watson Investigational Site

Carmel, Indiana, United States

Site Status

Watson Investigational Site

Jeffersonville, Indiana, United States

Site Status

Watson Investigational Site

Shreveport, Louisiana, United States

Site Status

Watson Investigational Site

Las Vegas, Nevada, United States

Site Status

Watson Investigational Site

Mount Laurel, New Jersey, United States

Site Status

Watson Investigational Site

Voorhees Township, New Jersey, United States

Site Status

Watson Investigational Site

Albany, New York, United States

Site Status

Watson Investigational Site

Syracuse, New York, United States

Site Status

Watson Investigational Site

Lancaster, Pennsylvania, United States

Site Status

Watson Investigational Site

Myrtle Beach, South Carolina, United States

Site Status

Watson Investigational Site

Dallas, Texas, United States

Site Status

Watson Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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Shore ND, Sieber P, Schimke L, Perzin A, Olsen S. Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer. Urol Nurs. 2013 Sep-Oct;33(5):236-44, 248.

Reference Type DERIVED
PMID: 24354113 (View on PubMed)

Other Identifiers

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TRE1001

Identifier Type: -

Identifier Source: org_study_id