ClinicalTrials.gg
RecruitingNCT04433897HARALDUpdated Apr 12, 2024

Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

An observational study in Nocturia, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by University Hospital, Ghent · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2018; still recruiting 8 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
40 Years to 65 Years
Sex
Female
01

Study summary

Aim of this study was to observe

The study was adjusted in two parts:

PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed.

PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.

02

Conditions studied

  • Nocturia

Browse trials for

03

In context

Nocturia

134 studies on the registry are indexed under Nocturia; 22 are open to participants now.

This study's planned enrollment of 300 is above the median of 150 across 21 observational studies indexed under Nocturia.

Browse Nocturia studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women who are biochochemically confirmed to be postmenopausal.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women with symptoms (hot flushes, atrophy, ..)
  • All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria

Exclusion criteria

Exclusion Criteria:

  • Intake of HRT on the moment of inclusion
  • women with thyroid dysfunction
  • women using antihypertensive agents
  • women with a history of psychiatric or neurological disorders
  • women with a history of alcohol or drug addiction.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Oral estrogen + IUD

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD

    Other: Questionnaire

  • Oral estrogen + hysterectomy

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.

    Other: Questionnaire

  • Oral estrogen + oral progesterone

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.

    Other: Questionnaire

  • Transdermal estrogen + IUD

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.

    Other: Questionnaire

  • Transdermal estrogen + hysterectomy

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.

    Other: Questionnaire

  • Transdermal estrogen + oral progesteron

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron

    Other: Questionnaire

  • SERM

    Women who opt to be treated for their postmenopausal symptoms using SERM's

    Other: Questionnaire

  • Aromatase inhibitor

    Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.

    Other: Questionnaire

  • Duavive

    Women who opt to be treated for their postmenopausal symptoms using duavive.

    Other: Questionnaire

  • No treatment

    Women who opt not to be treated for their postmenopausal symptoms.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    All women fulfilled 3 questionairres * TANGO * ICIQ -N * Perceived Stress Scale

06

What researchers measure

Primary outcomes

  1. Change in nocturnal Frequency

    Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire

    Time frame: 6 months after initiating therapy

Secondary outcomes

  1. Change in bother linked with nocturnal frequency

    Change in VAS scale of bother linked with nocturnal frequency

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Department of Urology, Ghent University
    Gent, Oost-Vlaanderen 9000, Belgium
    Recruiting
    • Kim Pauwaert, MD · Contactkim.pauwaert@uzgent.be · +32 93321182
    • An-Sofie Goessaert, MD, PhD · Contact
    • Kim Pauwaert, MD · Principal investigator
    • An-Sofie Goessaert, MD, PhD · Principal investigator
    • Karel Everaert, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2018 (actual). Primary completion is estimated for Dec 2025, 90 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2020
First posted
Jun 16, 2020
StartActual
Jun 1, 2018
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04433897
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Jun 1, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Kim Pauwaert
Contact
kim.pauwaert@ugent.be
093321182
Karel Everaert
Contact
Karel.Everaert@uzgent.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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