MedDataX Logo

Perimenopause and Menopause in Women With Spinal Cord Injury

NCT ID: NCT06709664

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is widespread knowledge and information about the perimenopause and menopause, its symptoms and treatment; all of this is for people without spinal cord injury (women will be used to denote all people who can or have undergone the perimenopause and menopause). There is paucity of data about this condition in women with spinal cord injury. These women are living longer lives and should be supported to live a healthy life.

Some studies have suggested that women with Spinal Cord Injury (wSCI) may undergo the perimenopause and menopause earlier than those without, however others have concluded that the age at the perimenopause and menopause is no different. wSCI may suffer less with vasomotor symptoms due to their ability to manage the symptoms of autonomic dysreflexia; however they may have more genito-urinary symptoms; also due to the need for self-catheterisation.

Hormone Replacement Therapy (HRT) has many benefits including reduction in risk of fractures by slowing down the development of osteoporosis, thereby reducing fracture risk and morbidity. Reduced mobility also puts them at an increased risk of cardio-vascular disease.

This study aims to gain information about these characteristics of the perimenopause and menopause in wSCI; the age at which they become menopausal and the most bothersome symptoms for them, treatment options offered to them as well as details of their spinal cord injury.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women with Spinal Cord Injury

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

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Questionnaire study

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 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.

Exclusion Criteria

* • Individuals who have yet to go through the perimenopause and/or menopause
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

James Cooper

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James Cooper

Research and Innovation Manager/Sponsor Representative

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sucheta Iyengar, BM

Role: CONTACT

[email protected]
01296 831378

James Cooper, BSc, MSc

Role: CONTACT

[email protected]
07816020305

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RXQ 1192

Identifier Type: -

Identifier Source: org_study_id