Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women (HARALD)

November 6, 2023 updated by: University Hospital, Ghent

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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Department of Urology, Ghent University
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who are biochochemically confirmed to be postmenopausal.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Oral estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Oral estrogen + oral progesterone
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Transdermal estrogen + IUD
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Transdermal estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Transdermal estrogen + oral progesteron
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
SERM
Women who opt to be treated for their postmenopausal symptoms using SERM's

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Aromatase inhibitor
Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
Duavive
Women who opt to be treated for their postmenopausal symptoms using duavive.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale
No treatment
Women who opt not to be treated for their postmenopausal symptoms.

All women fulfilled 3 questionairres

  • TANGO
  • ICIQ -N
  • Perceived Stress Scale

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EC 2018/0315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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