NCT06709664

Brief Summary

A lot of information is known about how the perimenopause and menopause affects able bodied women. However there is very little information about how these affects women with spinal cord injury. This questionnaire study aims to collect information from women with a spinal cord injury on their experiences of going through the perimenopause and/or the menopause.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 26, 2024

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To collect more information on determine signs, symptoms and severity of these signs and symptoms of the perimenopause and menopause in women with spinal cord injury

    * Information on menstrual cycle * Frequency of autonomic dysreflexia * Typical signs of autonomic dysreflexia * Menopausal symptoms * Treatment for menopausal symptoms * Satisfaction of medication (for menopausal symptoms) * Satisfaction of support for the perimenopause and menopause

    1 time point

Secondary Outcomes (1)

  • To collect more information on establish how SCI affects the experience of the perimenopause and menopause

    1 time point

Study Arms (1)

Women with Spinal Cord Injury

Women with Spinal Cord Injury who are currently going through or have gone through the Perimenopause/Menopause

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire study

Women with Spinal Cord Injury

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen will be used to denote all people who can or have undergone the perimenopause and menopause
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women will be used to denote all people who can or have undergone the perimenopause and menopause and have a clinical diagnosis of a spinal cord injury

You may qualify if:

  • Patient is willing and able to give informed consent for participation in the study (or verbally confirm they wish to take part if someone completing on their behalf)
  • Who has undergone or currently experiencing the perimenopause or menopause
  • Aged 18 years old or older
  • Clinically diagnosed with a spinal cord Injury at least 3 months ago
  • Is either a) currently going through the perimenopause and menopause or b) has been through the perimenopause and menopause.

You may not qualify if:

  • Individuals who have yet to go through the perimenopause and/or menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Sucheta Iyengar, BM

CONTACT

James Cooper, BSc, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research and Innovation Manager/Sponsor Representative

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 29, 2024

Study Start

January 1, 2025

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11