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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

251

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Nov 2010

Shorter than P25 for phase_1

Geographic Reach

3 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

November 1, 2010

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

October 23, 2012

Completed

Last Updated

October 23, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

November 29, 2010

Results QC Date

September 21, 2012

Last Update Submit

September 21, 2012

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

Part A - Cumulative Skin Irritation by Draize Score
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 \[mm\]).
Day 1 through Day 22
Part B - Skin Irritation and Sensitization by Draize Score
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. 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 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).
Days 1 - 19 and 34 - 37

Secondary Outcomes (2)

Part A - Patch Adhesion Score
Day 1 through Day 22
Part B - Patch Adhesion Score
Days 1 - 19 and 34 - 37

Study Arms (1)

LY333334 + placebo

EXPERIMENTAL

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

Drug: LY333334Drug: Placebo

Interventions

LY333334DRUG

Transdermal patch

LY333334 + placebo

PlaceboDRUG

Transdermal patch

LY333334 + placebo

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Are overtly healthy postmenopausal females, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests (for example, subjects who have osteoporosis or stable and/or controlled hyperlipidemia, hypertension, and/or hypothyroidism may be entered if that investigator judges it appropriate for participation in this study).
Postmenopausal women include women with at least 6-weeks postsurgical bilateral oophorectomy with or without hysterectomy, confirmed by medical history, or spontaneous amenorrhea for at least 6 to 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (eg, oral contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) and a follicle-stimulating hormone level greater than 40 mIU/mL.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have a sitting blood pressure and pulse rate that are judged to be not clinically significant by the investigator.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Have given written informed consent approved by Eli Lilly and Company (Lilly) and the ethical review board (ERB) governing the site.

You may not qualify if:

Are currently enrolled in, or discontinued within the last 3 months from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known hypersensitivity to teriparatide or to any of its excipients.
Are persons who have previously completed or withdrawn from this study or any other study investigating teriparatide patch.
Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
Have a history of breast cancer within the past 10 years or other types of carcinoma within the past 5 years, except for excised superficial skin tumors and adequately treated in situ carcinoma of cervix.
Have an average weekly alcohol intake that exceeds 14 units per week,
(1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Have hyperparathyroidism or hypoparathyroidism.
Have hyperthyroidism.
Have hypercalciuria (24-hour collection above 300 mg/day).
+14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (5)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Daytona Beach, Florida, 32117, United States

Location

Honolulu, Hawaii, 96814, United States

Location

München, 80636, Germany

Location

Schenefeld, 22869, Germany

Location

Plymouth, Devon, PL6 5HH, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 23, 2012

Results First Posted

October 23, 2012

Record last verified: 2012-09

Locations

DE(2)GB(1)US(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

LY333334 + placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations