NCT01250145

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	LY333334	Transdermal patch
DRUG	Placebo	Transdermal patch

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-11-30
• Last updated: 2012-10-23
• Results posted: 2012-10-23

Locations

5 sites across 3 countries: United States, Germany, United Kingdom