- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433897
Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women (HARALD)
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kim Pauwaert
- Phone Number: 093321182
- Email: kim.pauwaert@ugent.be
Study Contact Backup
- Name: Karel Everaert
- Email: Karel.Everaert@uzgent.be
Study Locations
-
-
Oost-Vlaanderen
-
Gent, Oost-Vlaanderen, Belgium, 9000
- Recruiting
- Department of Urology, Ghent University
-
Contact:
- Kim Pauwaert, MD
- Phone Number: +32 93321182
- Email: kim.pauwaert@uzgent.be
-
Contact:
- An-Sofie Goessaert, MD, PhD
-
Principal Investigator:
- Kim Pauwaert, MD
-
Principal Investigator:
- An-Sofie Goessaert, MD, PhD
-
Principal Investigator:
- Karel Everaert, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oral estrogen + IUD
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD
|
All women fulfilled 3 questionairres
|
Oral estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.
|
All women fulfilled 3 questionairres
|
Oral estrogen + oral progesterone
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.
|
All women fulfilled 3 questionairres
|
Transdermal estrogen + IUD
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.
|
All women fulfilled 3 questionairres
|
Transdermal estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.
|
All women fulfilled 3 questionairres
|
Transdermal estrogen + oral progesteron
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron
|
All women fulfilled 3 questionairres
|
SERM
Women who opt to be treated for their postmenopausal symptoms using SERM's
|
All women fulfilled 3 questionairres
|
Aromatase inhibitor
Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.
|
All women fulfilled 3 questionairres
|
Duavive
Women who opt to be treated for their postmenopausal symptoms using duavive.
|
All women fulfilled 3 questionairres
|
No treatment
Women who opt not to be treated for their postmenopausal symptoms.
|
All women fulfilled 3 questionairres
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nocturnal Frequency
Time Frame: 6 months after initiating therapy
|
Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
|
6 months after initiating therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bother linked with nocturnal frequency
Time Frame: 6 months
|
Change in VAS scale of bother linked with nocturnal frequency
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC 2018/0315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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