Clinical Performance and Usability Assessment of Hormona Perimenopause
Research type
Research Study
Full title
Clinical Performance and Usability Assessment of Hormona Perimenopause
IRAS ID
365049
Contact name
Anna Targonskaya
Contact email
Sponsor organisation
Wlness Science Ltd
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
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 accurately the system can measure natural changes in hormones during the perimenopausal transition.
Perimenopause is the stage leading up to menopause when hormone levels begin to fluctuate, often causing symptoms such as mood changes, sleep disturbances, and irregular menstrual cycles. The Hormona system combines simple urine tests that measure key hormones; Follicle Stimulating Hormone (FSH); Estrogen’s urinary metabolite Estrone-3-Glucuronide (E1G); and Progesterone’s urinary metabolite Pregnanediol Glucuronide (PdG); with an app that helps users track their results and daily symptoms in one place.
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 (how consistently and accurately the tests detect hormonal changes) in women aged 40–55 years.
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.
The study is sponsored by Wlness Science Ltd (trading as Hormona) and reviewed by a Research Ethics Committee. 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
REC name
HSC REC A
REC reference
25/NI/0156
Date of REC Opinion
18 Dec 2025
REC opinion
Further Information Favourable Opinion