Osteoporosis, PostmenopausalPhase 1NCT01250145

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

A Phase 1 study testing LY333334 in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Osteoporosis, Postmenopausal
What is being tested?: LY333334
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 251 participants
Where: 5 sitesin 3 countries
Study dates: Nov 2010to May 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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 all 30Show fewer

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).
Have hypercalcemia (above the upper limit of reference range).
Have a history of bone diseases such as Paget's disease of bone, bone carcinoma, bone metastases, metabolic bone disease other than osteoporosis, or unexplained elevation in serum alkaline phosphatase level.
Have a history of external beam or implant radiation involving the skeleton.
Have a history of recurrent nephrolithiasis, or a single episode within the past 5 years. Eligible subjects who have had an episode within the past 5 to 10 years must have a kidney-ureter-bladder X-ray of the abdominal area within 1 month prior to enrollment in the study, which indicates no existing stone.
Have a history of bleeding disorder within the past 3 years.
Are currently using therapies for osteoporosis; or using hormone replacement therapy or bisphosphonates during the previous 3 months. Women receiving short-term hormone therapy for the treatment of moderate to severe menopausal symptoms may be enrolled if their postmenopausal status is confirmed by inclusion criterion.
Have presence of a dermatologic disease that might interfere with the evaluation of the test site reaction; and clinically significant scars, wounds, or discoloration, or abnormalities of the skin at or near the intended site of electrode application (for example, porphyria, atopy, psoriasis, vitiligo).
Have a history of severe skin infection within the past year in the opinion of the investigator.
Have a history of skin allergy or hypersensitivity to tapes or adhesives, in the opinion of the investigator.
Have a history of significant dermatologic cancers (for example, melanoma, squamous cell carcinoma), except basal-cell carcinomas that were superficial and did not involve the investigative site.
Have an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application sites, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug.
Have implanted or externally mounted electrical or electronic medical devices (for example, pacemakers).
Have used topical analgesics or topical corticosteroids within 3 weeks of study enrollment.
Have taken antihistamines within 72 hours prior to dosing.
Any other condition which, in the opinion of the investigator, would preclude participation in the study.

Trial locations and contacts

5 sites in 3 countries.

Country

City, postcode or hospital

5 sites in 3 countries

United States2 sites

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
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.
Honolulu, Hawaii, 96814

Other trials in United States

Germany2 sites

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.
München, 80636
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.
Schenefeld, 22869

Other trials in Germany

United Kingdom1 site

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.
Plymouth, Devon, PL6 5HH

Other trials in United Kingdom

About this study

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
Being tested: LY333334, Placebo
Medical subject headings: Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY333334Drug
Transdermal patch
PlaceboDrug
Transdermal patch

Study groups in NCT01250145
Study group	Role	What they receive
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 Receives: Drug: LY333334; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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]).
Measured: 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).
Measured: Days 1 - 19 and 34 - 37

Secondary outcomes (2)

Part A - Patch Adhesion Score
Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Measured: Day 1 through Day 22
Part B - Patch Adhesion Score
Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Measured: Days 1 - 19 and 34 - 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted30 Nov 2010 (estimated)
Study startNov 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01250145
Sponsor's protocol ID: 13764
Other IDs: I2Y-EW-GHFO
Status last verified: Sep 2012
First submitted: 29 Nov 2010
Last updated: 23 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
ClinicalTrials.gov ID: NCT01250145
Acronym / sponsor ID: 13764
Conditions: Osteoporosis, Postmenopausal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 30 Nov 2010 (estimated)
Results: Posted 23 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
LY333334 + placebo	Experimental	Drug: LY333334, Drug: PlaceboPart 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

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (30 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY333334Transdermal patch	Drug	LY333334 + placebo
PlaceboTransdermal patch	Drug	LY333334 + placebo

Primary outcome

Part A - Cumulative Skin Irritation by Draize Score
Time frame: Day 1 through Day 22
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]).
Part B - Skin Irritation and Sensitization by Draize Score
Time frame: Days 1 - 19 and 34 - 37
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).

2 secondary outcomes

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

Results and safety

Results posted to the registry on 23 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY333334 + Placebo: Part A	41	39
LY333334 + Placebo: Part B	210	205

Primary outcome: Part A - Cumulative Skin Irritation by Draize Score

Time frame: Day 1 through Day 22. Number. Unit: patches with Draize scores

Measure	Part A: Active Patch - Prior to Patch Application n = 41	Part A: Active Patch - 1 Hour Post Patch Removal n = 41	Part A: Active Patch - 24 Hours Post Patch Application n = 41	Part A: Placebo Patch - Prior to Patch Application n = 41	Part A: Placebo Patch - 1 Hour Post Patch Removal n = 41	Part A: Placebo Patch - 24 Hours Post Patch Application n = 41
Erythema: Score 0	299	40	146	390	69	205
Erythema: Score 1	523	674	633	452	713	601
Erythema: Score 2	65	176	106	45	108	79
Erythema: Score 3	1	0	2	1	0	2
Edema: Score 0	604	113	370	716	298	539
Edema: Score 1	270	600	454	166	511	322
Edema: Score 2	13	175	62	5	80	26
Edema: Score 3	1	1	1	1	0	0

Population analysed: All participants who entered the study and received patches are included in the analysis.

Primary outcome: Part B - Skin Irritation and Sensitization by Draize Score

Time frame: Days 1 - 19 and 34 - 37. Number. Unit: patches with Draize scores

Measure	Part B: Active Patch - Prior to Patch Application n = 210	Part B: Active Patch - 1 Hour Post Patch Removal n = 210	Part B: Active Patch - 24 Hours Post Patch Application n = 210	Part B: Placebo Patch - Prior to Patch Application n = 210	Part B: Placebo Patch - 1 Hour Post Patch Removal n = 210	Part B: Placebo Patch - 24 Hours Post Patch Application n = 210
Erythema: Score 0	1399	122	436	1525	271	784
Erythema: Score 1	1050	1503	1899	924	1698	1578
Erythema: Score 2	30	840	138	25	495	107
Erythema: Score 3	0	14	1	0	10	0
Edema: Score 0	2280	930	1759	2330	1572	2014
Edema: Score 1	197	1141	661	143	766	435
Edema: Score 2	2	399	53	1	136	19
Edema: Score 3	0	5	1	0	0	1

Population analysed: All participants who entered the study and received patches are included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY333334 + Placebo: Part A	0 of 41 (0%)	31 of 41 (75.6%)	Not reported
LY333334 + Placebo: Part B	2 of 210 (1%)	157 of 210 (74.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis, Postmenopausal

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

5 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY333334 in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Cumulative Skin Irritation by Draize Score (time frame: Day 1 through Day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01250145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012; AzTrials last refreshed its copy on 26 Oct 2026.