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Study · Randomized controlled trial · n = 385 · 2013

11 results

Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study.

Weiss JP, Herschorn S, Albei CD, van der Meulen EA

The Journal of urology20 Feb 2013Cited by 61 (Europe PMC)

PMID23454402 (opens in a new tab)DOI10.1016/j.juro.2012.12.112 (opens in a new tab)PepBankPUB-23454402
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 trialEfficacy outcome

    In men with nocturia, desmopressin 50 μg reduced nocturnal voids versus placebo by 0.37 (p <0.0001).

    In plain wordsIn men with nocturia, desmopressin 50 μg reduced nightly urination more than placebo.

    Peptide
    Desmopressin
    Outcome
    DecreaseNocturnal voids
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    50 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Change in nocturnal voids vs placebo
    −0.37 voids
    desmopressin 50 μg vs placebo
    P value
    < 0.0001 unitless
    desmopressin 50 μg vs placebo

    Source sentences

    Summary
    The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin 75 μg reduced nocturnal voids versus placebo by 0.41 (p = 0.0003).

    In plain wordsIn men with nocturia, desmopressin 75 μg reduced nightly urination more than placebo.

    Peptide
    Desmopressin
    Outcome
    DecreaseNocturnal voids
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    75 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Change in nocturnal voids vs placebo
    −0.41 voids
    desmopressin 75 μg vs placebo
    P value
    0.0003 unitless
    desmopressin 75 μg vs placebo

    Source sentences

    Summary
    The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin 50 μg increased odds of at least 33% response versus placebo (OR 1.98, p = 0.0009).

    In plain wordsIn men with nocturia, desmopressin 50 μg increased response odds compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseAt least 33% response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    50 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Odds ratio for at least 33% response
    1.98 odds ratio
    desmopressin 50 μg vs placebo
    P value
    0.0009 unitless
    desmopressin 50 μg vs placebo

    Source sentences

    Summary
    The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin 75 μg increased odds of at least 33% response versus placebo (OR 2.04, p = 0.0004).

    In plain wordsIn men with nocturia, desmopressin 75 μg increased response odds compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseAt least 33% response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    75 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Odds ratio for at least 33% response
    2.04 odds ratio
    desmopressin 75 μg vs placebo
    P value
    0.0004 unitless
    desmopressin 75 μg vs placebo

    Source sentences

    Summary
    The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin significantly improved health-related quality of life compared with placebo.

    In plain wordsIn men with nocturia, desmopressin improved quality of life compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseHealth-related quality of life
    Study

    n = 385

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 and 75 μg · oral · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases in health related quality of life and sleep quality were observed compared to placebo.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin significantly improved sleep quality compared with placebo.

    In plain wordsIn men with nocturia, desmopressin improved sleep quality compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseSleep quality
    Study

    n = 385

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    50 and 75 μg · oral · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases in health related quality of life and sleep quality were observed compared to placebo.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin 50 μg increased time to first void by approximately 40 minutes versus placebo (p = 0.006).

    In plain wordsIn men with nocturia, desmopressin 50 μg delayed first urination by approximately 40 minutes compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseTime to first void
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    50 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Increase in time to first void from baseline
    ≈ 40 min
    desmopressin 50 μg vs placebo
    P value
    0.006 unitless
    desmopressin 50 μg vs placebo

    Source sentences

    Summary
    Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively).
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In men with nocturia, desmopressin 75 μg increased time to first void by approximately 40 minutes versus placebo (p = 0.003).

    In plain wordsIn men with nocturia, desmopressin 75 μg delayed first urination by approximately 40 minutes compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseTime to first void
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    75 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Increase in time to first void from baseline
    ≈ 40 min
    desmopressin 75 μg vs placebo
    P value
    0.003 unitless
    desmopressin 75 μg vs placebo

    Source sentences

    Summary
    Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively).
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  9. 09HumanRandomized controlled trialSafety outcome

    In men with nocturia, serum sodium below 130 mmol/L occurred in 2 subjects on 50 μg versus 9 on 75 μg.

    In plain wordsIn men with nocturia, low sodium occurred in 2 subjects on desmopressin 50 μg versus 9 on 75 μg.

    Peptide
    Desmopressin
    Outcome
    DecreaseSerum sodium below 130 mmol/L
    Study

    n: not reported in source

    Comparator
    75 μg desmopressin
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    50 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Subjects with serum sodium <130 mmol/L
    2 subjects
    50 μg desmopressin
    Subjects with serum sodium <130 mmol/L
    9 subjects
    75 μg desmopressin

    Source sentences

    Summary
    Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg).
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  10. 10HumanRandomized controlled trialSafety outcome

    In men with nocturia, serum sodium below 130 mmol/L occurred in 9 subjects on 75 μg versus 2 on 50 μg.

    In plain wordsIn men with nocturia, low sodium occurred in 9 subjects on desmopressin 75 μg versus 2 on 50 μg.

    Peptide
    Desmopressin
    Outcome
    IncreaseSerum sodium below 130 mmol/L
    Study

    n: not reported in source

    Comparator
    50 μg desmopressin
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    75 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Subjects with serum sodium <130 mmol/L
    9 subjects
    75 μg desmopressin
    Subjects with serum sodium <130 mmol/L
    2 subjects
    50 μg desmopressin

    Source sentences

    Summary
    Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg).
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
  11. 11HumanNon-randomized trialEfficacy outcome

    In men with nocturia, desmopressin response appeared by 1 week and persisted.

    In plain wordsIn men with nocturia, desmopressin response appeared by 1 week and persisted.

    Peptide
    Desmopressin
    Outcome
    Not applicableResponse onset and persistence
    Study

    n = 385

    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    50 and 75 μg · oral · 3 monthsAs given in this study (human).

    Measurements

    Time to response seen
    ≤ 1 week
    desmopressin 50 and 75 μg

    Source sentences

    Summary
    The response to desmopressin was seen by 1 week of treatment and was sustained.
    3 context sentences
    Summary · context
    We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).
    Summary · context
    In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo.
    Summary · context
    The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01262456

Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

Ferring Pharmaceuticalsn = 395Feb 2011 to Jan 2012

Nocturia

Trial pageClinicalTrials.govUpdated 15 Oct 2015

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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