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Study · Randomized controlled trial · n = 116 · 2013

13 results

Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo-controlled trial.

Yamaguchi O, Nishizawa O, Juul KV, Nørgaard JP

BJU international9 Oct 2012Cited by 39 (Europe PMC)

PMID23046147 (opens in a new tab)DOI10.1111/j.1464-410x.2012.11547.x (opens in a new tab)PepBankPUB-23046147
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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 study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 25 μg significantly reduced nocturnal voids versus placebo at day 28.

    In plain wordsIn Japanese nocturia patients, desmopressin 25 μg reduced night-time urination more than placebo.

    Peptide
    Desmopressin
    Outcome
    DecreaseNocturnal void reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    25 μg · oral · 28 daysAs given in this study (human).

    Measurements

    P value
    0.015 unitless
    reported result

    Source sentences

    Summary
    A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 50 μg significantly reduced nocturnal voids versus placebo at day 28.

    In plain wordsIn Japanese nocturia patients, desmopressin 50 μg reduced night-time urination more than placebo.

    Peptide
    Desmopressin
    Outcome
    DecreaseNocturnal void reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    50 μg · oral · 28 daysAs given in this study (human).

    Measurements

    P value
    < 0.001 unitless
    reported result

    Source sentences

    Summary
    A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 100 μg significantly reduced nocturnal voids versus placebo at day 28.

    In plain wordsIn Japanese nocturia patients, desmopressin 100 μg reduced night-time urination more than placebo.

    Peptide
    Desmopressin
    Outcome
    DecreaseNocturnal void reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    100 μg · oral · 28 daysAs given in this study (human).

    Measurements

    P value
    0.001 unitless
    reported result

    Source sentences

    Summary
    A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, single-dose desmopressin showed a dose-response relationship overall and within each gender.

    In plain wordsIn Japanese nocturia patients, higher desmopressin doses produced greater acute responses than lower doses in both genders.

    Peptide
    Desmopressin
    Outcome
    IncreaseAcute dose-response
    Study

    n = 116

    Comparator
    lower doses
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    10-100 μg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    In treatment period 1 a dose-response relationship was observed, both overall and in each gender group.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 25 μg produced 2 h of antidiuretic action, significantly longer than placebo.

    In plain wordsIn Japanese nocturia patients, desmopressin 25 μg prolonged antidiuretic action compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseDuration of antidiuretic action
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    25 μg · oral · single doseAs given in this study (human).

    Measurements

    Duration of antidiuretic action
    2 h
    reported result
    P value
    0.01 unitless
    reported result

    Source sentences

    Summary
    Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 50 μg produced 3.45 h of antidiuretic action, significantly longer than placebo.

    In plain wordsIn Japanese nocturia patients, desmopressin 50 μg prolonged antidiuretic action compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseDuration of antidiuretic action
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    50 μg · oral · single doseAs given in this study (human).

    Measurements

    Duration of antidiuretic action
    3.45 h
    reported result
    P value
    < 0.001 unitless
    reported result

    Source sentences

    Summary
    Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, desmopressin 100 μg produced 5.74 h of antidiuretic action, significantly longer than placebo.

    In plain wordsIn Japanese nocturia patients, desmopressin 100 μg prolonged antidiuretic action compared with placebo.

    Peptide
    Desmopressin
    Outcome
    IncreaseDuration of antidiuretic action
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    100 μg · oral · single doseAs given in this study (human).

    Measurements

    Duration of antidiuretic action
    5.74 h
    reported result
    P value
    < 0.001 unitless
    reported result

    Source sentences

    Summary
    Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Japanese nocturia patients, higher desmopressin doses produced greater reductions in nocturnal voids overall and within each gender at day 28.

    In plain wordsIn Japanese nocturia patients, higher desmopressin doses reduced night-time urination more than lower doses overall and within each gender.

    Peptide
    Desmopressin
    Outcome
    DecreaseClinical dose-response overall and by gender
    Study

    n: not reported in source

    Comparator
    lower doses
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    10-100 μg · oral · 28 daysAs given in this study (human).

    Source sentences

    Summary
    A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo.
    3 context sentences
    Summary · context
    Similar dose-response relationships were also seen when the data were analysed by gender.
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  9. 09HumanNon-randomized trialSafety outcome

    In Japanese nocturia patients, desmopressin was well tolerated with no serious adverse events.

    In plain wordsIn Japanese nocturia patients, no serious adverse events occurred with desmopressin.

    Peptide
    Desmopressin
    Outcome
    Not applicableSerious adverse events
    Study

    n = 116

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

    Source sentences

    Summary
    Desmopressin ODT was well tolerated with no serious or severe adverse events.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  10. 10HumanNon-randomized trialSafety outcome

    In Japanese nocturia patients, desmopressin was well tolerated with no severe adverse events.

    In plain wordsIn Japanese nocturia patients, no severe adverse events occurred with desmopressin.

    Peptide
    Desmopressin
    Outcome
    Not applicableSevere adverse events
    Study

    n = 116

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

    Source sentences

    Summary
    Desmopressin ODT was well tolerated with no serious or severe adverse events.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  11. 11HumanObservational studyEfficacy outcome

    In Japanese nocturia patients receiving desmopressin 25 μg, antidiuretic action lasted longer in females than males.

    In plain wordsIn Japanese nocturia patients receiving desmopressin 25 μg, antidiuretic action lasted longer in females than males.

    Peptide
    Desmopressin
    Outcome
    IncreaseGender difference in antidiuretic duration
    Study

    n: not reported in source

    Comparator
    male patients receiving the same dose
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    25 μg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    Female patients were found to be more sensitive to desmopressin; DOA in female patients was longer than in male patients after desmopressin 25 and 50 μg.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  12. 12HumanObservational studyEfficacy outcome

    In Japanese nocturia patients receiving desmopressin 50 μg, antidiuretic action lasted longer in females than males.

    In plain wordsIn Japanese nocturia patients receiving desmopressin 50 μg, antidiuretic action lasted longer in females than males.

    Peptide
    Desmopressin
    Outcome
    IncreaseGender difference in antidiuretic duration
    Study

    n: not reported in source

    Comparator
    male patients receiving the same dose
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    50 μg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    Female patients were found to be more sensitive to desmopressin; DOA in female patients was longer than in male patients after desmopressin 25 and 50 μg.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.
  13. 13HumanObservational studyOther

    In Japanese nocturia patients, extrapolation suggested males need approximately 58 μg desmopressin for antidiuretic duration similar to females receiving 25 μg.

    In plain wordsIn Japanese nocturia patients, extrapolation suggested males need more desmopressin than females for similar antidiuretic duration.

    Peptide
    Desmopressin
    Outcome
    Not applicableExtrapolated dose equivalence by gender
    Study

    n: not reported in source

    Comparator
    male patients
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    25 μg in females · oralAs given in this study (human).

    Measurements

    Extrapolated male dose for similar DOA
    ≈ 58 μg
    males, to match DOA of females receiving 25 μg

    Source sentences

    Summary
    Extrapolation suggests that male patients require ∼58 μg to achieve similar DOA to females receiving 25 μg.
    2 context sentences
    Summary · context
    A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted.
    Summary · context
    Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg.

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

    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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