Conditions: Osteoporosis, Postmenopausal
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 251
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Part A:

Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days

Part B:

Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours

Interventions: intervention 1: LY333334 intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal patch intervention 2: Transdermal patch

Protocol document: