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Study · Randomized controlled trial · 2004

11 results

Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction.

Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB

International journal of impotence research1 Feb 2004Cited by 80 (Europe PMC)

PMID14963471 (opens in a new tab)DOI10.1038/sj.ijir.3901139 (opens in a new tab)PepBankPUB-14963471
Publisher pagePubMedAsk about this study
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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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy male subjects, mean Cmax of intranasal PT‑141 increased in a dose-dependent manner.

    In plain wordsIn healthy men, blood peak levels of nasal PT‑141 rose as the dose went up.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseCmax in healthy subjects
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    In healthy subjects, mean C(max) and AUC((0-t)) increased in a dose-dependent manner.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy male subjects, mean AUC(0-t) of intranasal PT‑141 increased in a dose-dependent manner.

    In plain wordsIn healthy men, total blood exposure to nasal PT‑141 rose as the dose went up.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseAUC in healthy subjects
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    In healthy subjects, mean C(max) and AUC((0-t)) increased in a dose-dependent manner.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  3. 03HumanRandomized controlled trialPharmacokinetics

    Median Tmax of intranasal PT‑141 was 0.50 h.

    In plain wordsNasal PT‑141 reached its highest blood level after a median of 0.50 hours.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableMedian Tmax
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Measurements

    Tmax (median)
    0.5 h
    intranasal PT-141

    Source sentences

    Summary
    Median T(max) was 0.50 h
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  4. 04HumanRandomized controlled trialPharmacokinetics

    Mean elimination half-life of intranasal PT‑141 ranged from 1.85 to 2.09 h.

    In plain wordsThe half-life of nasal PT‑141 in the blood was about 1.85 to 2.09 hours.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableMean half-life (t1/2)
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Measurements

    t1/2 (mean)
    1.85 to 2.09 h
    intranasal PT-141

    Source sentences

    Summary
    mean t(1/2) ranged from 1.85 to 2.09 h.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In healthy males and in men with erectile dysfunction, intranasal PT‑141 induced a statistically significant erectile response versus placebo at doses above 7 mg.

    In plain wordsIn healthy men and men with erectile dysfunction, nasal PT‑141 caused more erection response than placebo at doses above 7 mg.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    IncreaseErectile response (RigiScan)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    >7 mg · intranasalAs given in this study (human).

    Source sentences

    Summary
    In both studies, an erectile response induced by PT-141 administration was statistically significant, compared to placebo, at doses greater than 7 mg
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  6. 06HumanRandomized controlled trialEfficacy outcome

    After intranasal PT‑141, the first erection began about 30 min after administration.

    In plain wordsAfter nasal PT‑141, the first erection started after about 30 minutes.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableOnset of first erection
    Study

    n: not reported in source

    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Measurements

    Time to onset of first erection
    ≈ 30 min
    after PT-141

    Source sentences

    Summary
    with the onset of the first erection occurring in approximately 30 min.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  7. 07HumanRandomized controlled trialSafety outcome

    Intranasal PT‑141 was reported as safely administered and well tolerated in both studies.

    In plain wordsNasal PT‑141 was reported as safe and well tolerated in both studies.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableOverall safety and tolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    PT-141 was safely administered and well tolerated in both studies.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  8. 08HumanRandomized controlled trialSafety outcome

    No maximum-tolerated dose of intranasal PT‑141 was identified.

    In plain wordsNo highest safe dose of nasal PT‑141 was found in these studies.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableMaximum-tolerated dose
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    A maximum-tolerated dose was not identified.
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  9. 09HumanRandomized controlled trialSafety outcome

    Flushing was among the most common adverse events with intranasal PT‑141 in both studies.

    In plain wordsFlushing was one of the most common side effects of nasal PT‑141 in both studies.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableFlushing
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    Flushing and nausea were the most common adverse events reported in both studies
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  10. 10HumanRandomized controlled trialSafety outcome

    Nausea was among the most common adverse events with intranasal PT‑141 in both studies.

    In plain wordsNausea was one of the most common side effects of nasal PT‑141 in both studies.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    Flushing and nausea were the most common adverse events reported in both studies
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.
  11. 11HumanRandomized controlled trialSafety outcome

    No clinically significant changes in vital signs, laboratory tests, ECGs or physical exams were observed with intranasal PT‑141.

    In plain wordsNasal PT‑141 caused no clinically significant changes in vital signs, lab tests, heart tracings or physical exams.

    Peptide
    Bremelanotide (PT-141)
    Outcome
    No significant changeVital signs, laboratory tests, ECG and physical exam
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasalAs given in this study (human).

    Source sentences

    Summary
    no clinically significant changes in vital signs, laboratory tests, ECGs, or physical exams were observed
    2 context sentences
    Summary · context
    PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients.
    Summary · context
    Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS.

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.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:04 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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