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Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer

NCT01161563•Watson Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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

Locations (16)

Watson Investigational Site

Homewood, Alabama, United States

Watson Investigational Site

Daytona Beach, Florida, United States

Watson Investigational Site

Orange City, Florida, United States

Watson Investigational Site

Coeur d'Alene, Idaho, United States

Watson Investigational Site

Carmel, Indiana, United States

Watson Investigational Site

Jeffersonville, Indiana, United States

Watson Investigational Site

Shreveport, Louisiana, United States

Watson Investigational Site

Las Vegas, Nevada, United States

Watson Investigational Site

Mount Laurel, New Jersey, United States

Watson Investigational Site

Voorhees Township, New Jersey, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

September 6, 2013

Enrollment

118

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Triptorelin pamoate

DRUG

Leuprolide acetate

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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