NocturiaHARALDNCT04433897
Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
An observational study of Nocturia, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2018to 31 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are biochochemically confirmed to be postmenopausal.
Who may be able to join
- Women with postmenopausal 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Karel Everaert contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Urology, Ghent University
Ghent, Oost-Vlaanderen, 9000
Kim Pauwaert, MD, +32 93321182, kim.pauwaert@uzgent.be
An-Sofie Goessaert, MD, PhD
About this study
Official title: Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
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.
- Conditions
- Nocturia
- Being tested
- Questionnaire
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
All women fulfilled 3 questionairres
- TANGO
- ICIQ -N
- Perceived Stress Scale
| Study group | Role | What they receive |
|---|---|---|
| Oral estrogen + IUD | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD Receives: Other: Questionnaire | |
| Oral estrogen + hysterectomy | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy. Receives: Other: Questionnaire | |
| Oral estrogen + oral progesterone | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone. Receives: Other: Questionnaire | |
| Transdermal estrogen + IUD | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD. Receives: Other: Questionnaire | |
| Transdermal estrogen + hysterectomy | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy. Receives: Other: Questionnaire | |
| Transdermal estrogen + oral progesteron | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron Receives: Other: Questionnaire | |
| SERM | Women who opt to be treated for their postmenopausal symptoms using SERM's Receives: Other: Questionnaire | |
| Aromatase inhibitor | Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor. Receives: Other: Questionnaire | |
| Duavive | Women who opt to be treated for their postmenopausal symptoms using duavive. Receives: Other: Questionnaire | |
| No treatment | Women who opt not to be treated for their postmenopausal symptoms. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nocturnal Frequency
Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433897
- Sponsor's protocol ID
- EC 2018/0315 (BC-02592)
- Acronym
- HARALD
- Status last verified
- Apr 2024
- First submitted
- 12 Jun 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided