Usability and accuracy of the Hormona at-home perimenopause test kit and mobile app
| ISRCTN | ISRCTN13282875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13282875 |
| Integrated Research Application System (IRAS) | 365049 |
| Protocol number | HPERI-CPS001 |
| Sponsor | Wlness Science LTD |
| Funder | Wlness Science LTD |
- Submission date
- 08/01/2026
- Registration date
- 13/01/2026
- Last edited
- 12/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This observational study is being conducted to understand how well women can use the Hormona Perimenopause test kit and mobile app at home, and how the system can measure natural changes in hormones during the perimenopausal transition. The purpose of this study is to evaluate the usability of the Hormona system (how easy it is to use, understand, and interpret) and its clinical performance (the device's ability to provide results that correlate with a specific health condition or biological process) in women aged 40–55 years.
Who can participate?
Women aged 40–55 years.
What does the study involve?
The study is observational and non-interventional, meaning that participants will perform the tests themselves at home and record their experiences. No medical treatment or clinical procedures are involved, and the results are for informational purposes only.
Participants will log symptoms daily in the Hormona app, complete a few short questionnaires, and perform several at-home urine tests according to their individual cycle schedule. All data will be anonymised and used solely for research purposes.
What are the possible benefits and risks of participating?
Findings will be used to refine Hormona’s technology and support its continued development as a regulated tool to help women better understand their hormonal health during perimenopause.
Participants might feel a little frustrated when using the app or trying to understand the test results; that’s understandable and completely normal. It’s important to note that the hormone test results provided during this study are for informational purposes only and are not diagnostic. They do not replace professional medical advice. If there are any concerns about participants’ health during the study, they should contact their doctor for support.
Participants' personal and health information will be kept secure. While there is always a remote risk to privacy, the company follows strict data protection rules under our Privacy Policy, which fully complies with UK GDPR. To help keep participants' information even safer, it is recommended that participant secure their phones with Face ID or a passcode in their device settings to protect against unauthorized access to the Hormona App and the data logged there.
Where is the study run from?
Wlness Science Ltd (trading as Hormona)
When is the study starting and how long is it expected to run for?
January 2026 to March 2026.
Who is funding the study?
Wlness Science Ltd (trading as Hormona)
Who is the main contact?
Anna Targonskaya, anna@hormona.io
Contact information
Principal investigator, Scientific, Public
Wlness Science Ltd, 5th Floor, 167-169 Great Portland Street
London
W1W 5PF
United Kingdom
| anna@hormona.io |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cross sectional study |
| Scientific title | Clinical performance and usability assessment of hormona perimenopause |
| Study objectives | The main purpose of this study is to understand how women experience and use the Hormona Perimenopause at-home hormone test and app, and how well the system tracks hormone changes during the perimenopause transition. The study aims to: - Observe changes in hormones related to fertility function during perimenopause. - Assess how easy the Hormona Perimenopause system is to use at home. |
| Ethics approval(s) |
Approved 18/12/2025, Health and Social Care Research Ethics Committee A (HSC REC A) (Lissue Industrial Estate West, 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 (028) 95 361400; info.orecni@hscni.net), ref: 25/NI/0156 |
| Health condition(s) or problem(s) studied | Perimenopause and menopause |
| Intervention | The study is designed to assess the performance of the Hormona Perimenopause self-test system, as well as the usability and comprehension of the test kit and mobile app among a representative group of women with diverse backgrounds and demographics. Importantly, this is a non-interventional (observational) study. Participants will not receive any medical advice, diagnosis, or treatment based on their test results. The study will not influence or alter participants’ usual healthcare, medication, or lifestyle decisions in any way. Data are collected solely to evaluate the device’s performance and user experience under normal conditions of use. Participants will be women aged 40 to 55, living in Great Britain (excluding Wales). Recruitment will take place via email invitation. Interested individuals will complete an eligibility questionnaire, and inclusion will be determined by the Principal Investigator based on predefined criteria. Eligible participants will then be invited by email to confirm their willingness to take part and provided with a Participant Information Sheet and Informed Consent Form to review and sign before enrolment. Once consent is received, participants will be sent an onboarding email and Participant Protocol containing detailed study information. Following enrolment, participants will receive their Hormona Perimenopause test kit, which includes printed Instructions for Use and a reusable urine collection cup. At the end of the study, participants will receive an end-of-study email with a link to complete the post-study questionnaire. Participants will be instructed to: - Perform hormone self-testing at home using first-morning urine, according to their personalised schedule in the app. - Log daily symptoms in the Hormona app. - Complete short user diaries after each testing day. - Fill out a post-study questionnaire to provide feedback on usability and comprehension. No biological samples will be sent to a laboratory, and no medical or clinical decisions will be based on test results. The results displayed in the app are for informational purposes only and are not a substitute for medical advice. This study design enables a comprehensive evaluation of both the clinical performance and usability of the device in a natural, real-world setting, while maintaining an entirely observational nature. The study is conducted fully remotely, without any clinical visits, direct contact with healthcare professionals, or deviation from participants’ usual behaviour or medical care, allowing participants to complete all activities comfortably from home. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hormona Perimenopause |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Age between 40 and 55 years. 2. Own a compatible smartphone (Android 6.0 or later, or iOS 13.4 or later) 3. Located in England and Scotland |
| Key exclusion criteria | 1. Currently pregnant 2. Currently breastfeeding 3. Using hormonal contraceptives (including oral, implant, patch, or IUD) 4. Receiving hormone replacement therapy (HRT) 5. Diagnosed with any of the following conditions: Hormone-related disorders (e.g. PCOS, thyroid dysfunction), mood disorders (e.g. depression, bipolar disorder), dementia or significant cognitive impairment, kidney, liver, or cardiovascular disease |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centre
London
W1W5PF
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
12/01/2026: Study’s existence confirmed by the Health and Social Care Research Ethics Committee A (HSC REC A), UK.
