NCT05299983

Brief Summary

As part of a National Institute on Aging -funded R01, the investigators developed an evidence-based, multi-media digital resource entitled MyMenoPlan to help women learn about the menopause transition, and the symptoms and treatments of perimenopause/menopause. MyMenoPlan is also designed to help women learn about the effectiveness of treatments for a comprehensive list of midlife symptoms and compare treatments that may help with the specific symptoms women are experiencing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 1, 2022

Results QC Date

August 2, 2023

Last Update Submit

March 25, 2025

Conditions

Keywords

Computer-Assisted Decision MakingInternet-Based Intervention

Outcome Measures

Primary Outcomes (4)

  • Perceived Quality of Information

    This 7-item, 5-point Likert scale (1- Strongly disagree to 5 - Strongly agree) is adapted from the Post-Study System Usability Questionnaire (PSSUQ) in Lewis (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (perceived quality of information). Items: 1. Reading the information made me feel in more control of my perimenopause/menopause. 2. The information on the website(s) was helpful to me. 3. I found the information I was looking for. 4. The information answered my questions about perimenopause/menopause. 5. I liked the website (s). 6. I would have liked more in-depth information. (reverse-coded) 7. The website(s) were fairly comprehensive about perimenopause /menopause.

    Each survey question is answered after spending at least 20 minutes on the assigned website(s)

  • Readability

    This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree)scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (readability). Items: 1. The information I read was clear. 2. The information I read was easy for me to understand.

    Each survey question is answered after spending at least 20 minutes on the assigned website(s)

  • Self-Efficacy for Managing Menopause Symptoms

    This is a newly developed Likert scale (1- Strongly disagree to 5 - Strongly agree) for assessing participants' beliefs in their own abilities in managing menopausal symptoms. The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (self-efficacy). Items: 1. If I want to, I am certain I could figure out the treatments or coping strategies that would work best for me. 2. I feel I could treat or cope with my symptoms of perimenopause/menopause if I want to.

    Each survey question is answered after spending at least 20 minutes on the assigned website(s)

  • Credibility

    This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree) scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (credibility). Items: 1. The information is credible. 2. The information is trustworthy.

    Each survey question is answered after spending at least 20 minutes on the assigned website(s)

Study Arms (2)

MyMenoPlan

EXPERIMENTAL

Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.

Other: MyMenoPlan

Control

ACTIVE COMPARATOR

Participants are asked to spend at least 20 minutes on at least one of the following websites or other websites of their choice: 1. North American Menopause Society: https://www.menopause.org/for-women 2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause 3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause

Other: Control

Interventions

Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.

MyMenoPlan
ControlOTHER

Participants are asked to spend at least 20 minutes on at least one of the following websites: 1. North American Menopause Society: https://www.menopause.org/for-women 2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause 3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause

Control

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on self-representation of gender identity this study includes females, non-binary people and transgender men defined as follows: Non-binary: a non-binary person is someone who does not identify as exclusively a man or a woman. Transgender male: A transgender male is a man who was assigned female at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • As stated above

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • Snyder LB, Newton KM, Ng HX, Reed SD, Guthrie KA, Zambrano V, LaCroix AZ. Positive impact of a menopause website - MyMenoplan.org - on treatment intentions, knowledge, and decision making: A randomized controlled trial. Maturitas. 2025 Aug;199:108630. doi: 10.1016/j.maturitas.2025.108630. Epub 2025 Jun 5.

Results Point of Contact

Title
Andrea LaCroix
Organization
UC San Diego

Study Officials

  • Andrea Z. LaCroix, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Epidemiology

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 29, 2022

Study Start

January 15, 2022

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

March 27, 2025

Results First Posted

March 27, 2025

Record last verified: 2025-03

Locations