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NCT01250145 · ClinicalTrials.gov registry record · Phase 1
A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 251
- Enrollment target
NCT01250145: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01250145 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 251 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (318% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250145, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 251 participants
- Enrollment target
Study 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.
Primary Outcome
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).
Interventions
- DRUG Placebo
- DRUG LY333334
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01250145 record still lists
NCT01250145 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (318% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01250145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01250145 about?
NCT01250145 is a clinical study titled "A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women". 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...
What is the current status of trial NCT01250145?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 251 participants. The study started on 2010-11. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01250145?
The interventions under investigation include: Placebo (DRUG), LY333334 (DRUG).
Who is sponsoring clinical trial NCT01250145?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01250145's enrollment target sits among peer trials
251 172nd of 2000 higher than 1,828 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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