drugset / Trial / NCT01250145

A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women

NCT01250145

Phase 1 Completed 251 enrolled Eli Lilly and Company
RandomizedSingle-groupDouble-blindTreatment

Summary

This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized, placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy postmenopausal women. Part A will examine the cumulative irritation and adherence of the transdermal patch, and Part B will examine skin sensitization and adherence. Two separate groups of subjects will be enrolled for Part A and Part B of the study. All screening procedures will take place up to 28 days prior to enrollment.

Timeline

Start
2010-11
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic 80 ug Other