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

NCT01250145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2012-10-23

Study results available
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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

DRUG

LY333334

Transdermal patch

DRUG

Placebo

Transdermal patch

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01250145 on ClinicalTrials.gov