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

NCT01161563 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-09-06

Study results available
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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.

Conditions

Interventions

DRUG

Triptorelin pamoate

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

DRUG

Leuprolide acetate

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

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Marilyn McIlwain, BS · Watson Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01161563 on ClinicalTrials.gov