Non-invasive measurement of vaginal tissue hydration in women with and without GSM

Non-invasive measurement of vaginal tissue hydration in women with and without GSM - HAVA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56226

Enrollment

Registered

2021-07-06

Start date

2025-06-18

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary syndrome of menopause (GSM) Vaginal atrophy Vulvar and vaginal dryness

Interventions

Corneometer®&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1: women with GSM - Age: >55 years old - Starting standard medical treatment with vaginal oestrogen - Presence of GSM will be determined by (1) the most bothersome symptom approach (MBS: vaginal dryness, vaginal/vulvar irritation/itching, vaginal/vulvar soreness, and dyspareunia), (2) physical examination (vaginal physical examination scale (Greenadle et al. (1999)), (3) vaginal pH of 6.0 or higher. Group 2: women without GSM - Age: 20 - 45 years old - Reason for attending clinic: benign gynaecological conditions

Exclusion criteria

Exclusion criteria: Group 1: women with GSM 1. Prior (trans)vaginal surgery 2. (History of) oncological or pre-oncological gynaecological disease 3. Already started treatment with vaginal oestrogen Group 2: non-GSM group 1. Signs or symptoms of GSM 2. Currently using vaginal oestrogen treatment 3. Prior (trans)vaginal surgery 4. (History of) oncological or pre-oncological gynaecological disease 5. The following vaginal conditions: lichen planus, symptomatic candidiasis, bacterial vaginosis.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the reproducibility of the Corneometer® as a measurement instrument to quantify hydration of the vulva and vaginal wall, evaluated by intra- and interobserver agreement.	—

Secondary

Measure	Time frame
Secondary study parameters are: 1. Response to treatment for GSM using vaginal oestrogen, as measured with the Corneometer®. 2. Differences in vaginal hydration measurements between women with and without GSM. 3.Correlations between vaginal hydration measurements and: a. Objective measure of GSM: pH b. Subjective measure of GSM: most bothersome symptom approach (MBS) c. Subjective measure of improvement: Patient Global Impression of Improvement (PGI-I)	—

Measure

Time frame

Secondary study parameters are: 1. Response to treatment for GSM using vaginal oestrogen, as measured with the Corneometer®. 2. Differences in vaginal hydration measurements between women with and without GSM. 3.Correlations between vaginal hydration measurements and: a. Objective measure of GSM: pH b. Subjective measure of GSM: most bothersome symptom approach (MBS) c. Subjective measure of improvement: Patient Global Impression of Improvement (PGI-I)

—

Countries

Netherlands

Contacts

Public ContactJ.P.W.R. Roovers

Bergman Clinics Vrouw

wetenschap.vrouw@bergmanclinics.nl+31 (0)88 9906816

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026