Successful transdermal administration of therapeutic doses of a polypeptide to normal human volunteers.

Meyer BR, Kreis W, Eschbach J, O'Mara V, Rosen S, Sibalis D

Clinical pharmacology and therapeutics1 Dec 1988Cited by 35 (Europe PMC)

PMID3143511DOI10.1038/clpt.1988.201PepBankPUB-03143511

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

2 results from studies that gave the peptide. 2 results from people.

01HumanNon-randomized trialEfficacy outcome
In normal men, passive leuprolide patches produced no luteinizing hormone elevation, with 11.8 mIU/ml at 4 hours.
In plain wordsIn normal men, leuprolide patches without current did not raise luteinizing hormone, which measured 11.8 mIU/ml at 4 hours.
Peptide
Leuprolide
Outcome
No significant changePassive patch luteinizing hormone response
Study
n = 13
Comparator
Baseline
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
5 mg · transdermalAs given in this study (human).
Measurements
LH
11.8 mIU/ml
passive patch at 4 hours
Source sentences
Summary
As predicted, passive patches produced no elevation of LH concentration (LH = 11.8 +/- 7.1 mIU/ml at 4 hours).
2 context sentences(design, population, supporting numbers)
Summary · context
This double-blind, randomized, crossover study in 13 normal men evaluated whether a low level of electrical current could induce changes in cutaneous permeability sufficient to produce absorption of a polypeptide.
Summary · context
We compared cutaneous absorption of 5 mg of leuprolide (a 9 amino acid luteinizing hormone releasing hormone analogue) in transdermal patches containing 0.2 mA electrical current (active) and in patches containing no electrical current (passive).
Report a problemFND-0314351102
02HumanNon-randomized trialSafety outcome
In normal men, leuprolide patches were well tolerated without significant cutaneous toxicity.
In plain wordsIn normal men, leuprolide patches were well tolerated without significant skin toxicity.
Peptide
Leuprolide
Outcome
Not applicableCutaneous toxicity and tolerability
Study
n = 13
Outcome group
Adverse events · Skin and wound
Studied dose
5 mg · transdermalAs given in this study (human).
Source sentences
Summary
The patches were well tolerated without significant cutaneous toxicity.
2 context sentences(design, population, supporting numbers)
Summary · context
This double-blind, randomized, crossover study in 13 normal men evaluated whether a low level of electrical current could induce changes in cutaneous permeability sufficient to produce absorption of a polypeptide.
Summary · context
We compared cutaneous absorption of 5 mg of leuprolide (a 9 amino acid luteinizing hormone releasing hormone analogue) in transdermal patches containing 0.2 mA electrical current (active) and in patches containing no electrical current (passive).
Report a problemFND-0314351105

Studies that did not test the peptide alone3

In this study, Leuprolide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Leuprolide.

03HumanNot a test of Leuprolide aloneRandomized controlled trialEfficacy outcome
In normal men, leuprolide patches with 0.2 mA electrical current (active) raised luteinizing hormone significantly more than leuprolide patches without current (passive), p = 0.0084.
In plain wordsIn normal men, leuprolide patches with electrical current raised luteinizing hormone more than leuprolide patches without current.
Peptide
Leuprolide
Outcome
IncreaseLuteinizing hormone elevation
Study
n = 13
Comparator
Passive patch without electrical current
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
Significant elevations of LH were seen in active compared with passive patches (p = 0.0084).
2 context sentences(design, population, supporting numbers)
Summary · context
This double-blind, randomized, crossover study in 13 normal men evaluated whether a low level of electrical current could induce changes in cutaneous permeability sufficient to produce absorption of a polypeptide.
Summary · context
We compared cutaneous absorption of 5 mg of leuprolide (a 9 amino acid luteinizing hormone releasing hormone analogue) in transdermal patches containing 0.2 mA electrical current (active) and in patches containing no electrical current (passive).
In this study, Leuprolide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Leuprolide.
Report a problemFND-0314351101
04HumanNot a test of Leuprolide aloneRandomized controlled trialEfficacy outcome
In normal men, leuprolide patches with 0.2 mA electrical current (active) produced LH of 56.4 mIU/ml at 4 hours, significantly above leuprolide patches without current (p = 0.003).
In plain wordsIn normal men, leuprolide patches with electrical current produced higher luteinizing hormone at 4 hours than patches without current.
Peptide
Leuprolide
Outcome
IncreaseLuteinizing hormone at 4 hours
Study
n = 13
Comparator
Passive patch without electrical current
Outcome group
Sex hormones and fertility · Endocrine and hormones
Measurements
LH
56.4 mIU/ml
active patch at 4 hours
Source sentences
Summary
However, active patches produced elevations comparable to those achieved with subcutaneous administration of the drug (LH = 56.4 +/- 49.6 mIU/ml at 4 hours and p = 0.003 compared with passive).
2 context sentences(design, population, supporting numbers)
Summary · context
This double-blind, randomized, crossover study in 13 normal men evaluated whether a low level of electrical current could induce changes in cutaneous permeability sufficient to produce absorption of a polypeptide.
Summary · context
We compared cutaneous absorption of 5 mg of leuprolide (a 9 amino acid luteinizing hormone releasing hormone analogue) in transdermal patches containing 0.2 mA electrical current (active) and in patches containing no electrical current (passive).
In this study, Leuprolide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Leuprolide.
Report a problemFND-0314351103
05HumanNot a test of Leuprolide aloneNon-randomized trialEfficacy outcome
In normal men, leuprolide patches with 0.2 mA electrical current produced luteinizing hormone elevations described as comparable to those with subcutaneous administration.
In plain wordsIn normal men, leuprolide patches with electrical current raised luteinizing hormone to levels described as comparable to subcutaneous leuprolide.
Peptide
Leuprolide
Outcome
Direction not reportedLuteinizing hormone response versus subcutaneous administration
Study
n: not reported in source
Comparator
Subcutaneous leuprolide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
However, active patches produced elevations comparable to those achieved with subcutaneous administration of the drug (LH = 56.4 +/- 49.6 mIU/ml at 4 hours and p = 0.003 compared with passive).
2 context sentences(design, population, supporting numbers)
Summary · context
This double-blind, randomized, crossover study in 13 normal men evaluated whether a low level of electrical current could induce changes in cutaneous permeability sufficient to produce absorption of a polypeptide.
Summary · context
We compared cutaneous absorption of 5 mg of leuprolide (a 9 amino acid luteinizing hormone releasing hormone analogue) in transdermal patches containing 0.2 mA electrical current (active) and in patches containing no electrical current (passive).
In this study, Leuprolide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Leuprolide.
Report a problemFND-0314351104

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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