Outcome measurements
| Outcome measurements | Explanation | Time points for assessment |
| VAS | VAS evaluates the change in six categories of symptoms commonly associated with vulvovaginal atrophy: vaginal pain, burning, itching, dryness, dyspareunia and dysuria. VAS will be scored on an 11-point scale for each symptom, with 0 being the lowest level (none) and 10 being the highest (extreme).19–22 | T0, T1, T2 and T3 |
| FSFI | The FSFI evaluates six subscales and one sum of scores that measure the degree of desire, excitement, lubrication, orgasm, satisfaction and pain (dyspareunia). The scores of the subscales are corrected and added up, resulting in a final score. Final scores can range from 2 to 36. Higher scores indicate a better degree of sexual function.23–25 | T0, T1, T2 and T3 |
| VHI | VHI scores of vaginal moisture, vaginal fluid volume, vaginal elasticity, pH and vaginal epithelial integrity on a scale of 1 (most inferior) to 5 (best) will be found. Vaginal moisture is an assessment of the appearance or consistency of the secretions that line the vagina. Vaginal elasticity is a measurement of the vaginal tissue’s ability to stretch at the examiner’s touch. Epithelial integrity takes into account colour, thickness and the absence of vaginal bleeding. The lower the score, the higher the atrophy.4 The sum of the values of the evaluated parameters results in the total vaginal health score. When the overall score is less than 15, the vaginal mucosa is considered atrophic.19 27 | T0, T1, T2 and T3 |
| SF-12 | The SF-12 provides accurate and efficient information to assess physical and mental health. It includes eight dimensions as the initial SF-36 instrument: general health perceptions (one item), physical functioning (two items), role limitations due to physical problems (two items), bodily pain (one item), vitality (one item), social functioning (one item), role limitations due to emotional problems (two items) and mental health (two items). The composite physical (PCS) and mental health (MCS) scores are computed using the scores of the 12 items, ranging from 0 to 100, where zero reflects the lowest health level and 100 the highest level.20–22 26 | T0, T1, T2 and T3 |
FSFI, Female Sexual Function Index; MCS, mental component summary; PCS, physical component summary; SF-12, Short Form 12; VAS, Visual Analogue Scale; VHI, Vaginal Health Index.