The first oral prescription treatment that does not contain hormones, for post-menopausal women with moderate to severe symptomatic vulvovaginal atrophy (VVA) 4-6

The impact of VVA

The symptoms of vulvovaginal atrophy (VVA) can have a significant impact on a woman’s life1

Over 60% of post-menopausal women suffer from the symptoms of VVA, such as vaginal dryness and dyspareunia1-3

What is VVA?

Healthy pre-menopausal vaginal epithelium

Vaginal epithelium following low oestrogen levels

Well lubricated and thick vaginal epithelium

 

- Stratified squamous epithelium

- Thickened rugated surface2-4

- Moist2

- pH ≤ 4.52

Thinning of vaginal epithelium and loss of lubrication

 

- Thinner epithelium2-4

- Flattening of rugae and reduced elasticity2-4

- Increased connective tissue in relation to epithelium2-4 

- Decrease in blood flow and vaginal lubrication2-4

- Increased pH (≥4.6)2

 

This leads to vulvovaginal atrophy (VVA), which is associated with a number of symptoms, such as dyspareunia (pain with intercourse), vaginal dryness, and irritation.1

Symptoms, including dyspareunia, may affect sexual activities, relationships, daily activities, and quality of life.1

There are an estimated 13 million women in the post-menopausal age group in the UK5

Over 60% of post-menopausal women suffer from the symptoms of VVA, such as vaginal dryness and dyspareunia6-8

Half of post-menopausal women, aged 45-75 years, are sexually active9

 

Symptoms of VVA can impair everyday life, sexual relationships and physical intimacy of post-menopausal women and their partners6, 10, 11

60% of women with postmenopausal vaginal discomfort will avoid physical intimacy11

Symptoms of VVA:

  • Impair the quality of a woman’s sex life and relationship, causing significant emotional distressreduced self-esteem and well-being11
  • Impact on everyday life, including her sleepenjoyment of life and temperament6,10

 

More than half of women with vaginal discomfort are untreated12

63% of post-menopausal women do not know that vaginal discomfort is a chronic condition6, the underlying cause of which can usually be treated.

Dissatisfaction with current treatment options is high10,13

Only 45% of women are satisfied with the treatments available for vulvovaginal atrophy14

  • Some women receiving OTC treatment have concerns over efficacy10 
  • Some women have a fear of using hormones13
  • Vaginal oestrogens are contraindicated in women with a history of breast cancer15-17
  • Some women dislike the route of administration and messiness of available treatments13
  • 39% of women find local therapies uncomfortable to apply10
  • Some women are physically not able to apply local oestrogens13

Women may be too embarrassed or uncomfortable to discuss their symptoms, but they need your help in managing their VVA1

Just over half of post-menopausal women with VVA have discussed symptoms with their healthcare professional10

Without help from someone knowledgeable, a lot of women with VVA could be…

…Afraid to speak and suffering in silence without knowing how to bring up the subject

…Unaware their symptoms are treatable

…Dissatisfied with using treatments they don’t like

Diagnosing VVA

Validated tools such as the Vaginal Health Index (VHI), which includes vaginal pH measure, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire can be useful in evaluating VVA19, 22

 

Patient symptoms2

Signs on visual examination20

Laboratory findings2

Vaginal health index (VHI)19,21

Vaginal dryness

Vaginal pain associated with sexual activity (dyspareunia)

Vaginal and/or vulvar irritation or itching

Dysuria

Vaginal bleeding associated with sexual activity

Pallor

Redness

Petechiae

Dryness

Friability

<5% superficial cells on VMI

Vaginal pH of ≥4.6

Lower score corresponds to greater urogenital atrophy

 

Vaginal Health Index (VHI)13

 

Score Overall elasticity* Fluid secretion type and consistency pH Epithelial mucosa Moisture
1 None None 6.1 Petechiae noted before contact None, mucosa inflamed
2 Poor Scant, thin yellow 5.6-6.0 Bleeds with light contact None, mucosa not inflamed
3 Fair Superficial, thin white 5.1-5.5 Bleeds with scraping Minimal
4 Good Moderate, thin white 4.7-5.0 Not friable, thin mucosa Moderate
5 Excellent Normal (white flocculent) ≤4.6 Not friable, normal mucosa Normal

*Lower score corresponds to greater urogenital atrophy

 

The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire

The DIVA questionnaire is designed to evaluate the impact of vaginal symptoms on women’s activities of daily living, emotional well-being, sexual functioning, and self-concept and body image22

References:

  1. Kingsberg S, et al. J Sex Med 2013; 10(7): 1790–1799.
  2. MacBride M, et al. Mayo Clin Proc 2010; 85: 87–94.
  3. The North American Menopause Society. Menopause 2013; 20: 888-902.
  4. Sturdee D and Panay N. Climacteric 2010; 13: 509-522.
  5. Office for National Statistics. Table A2-1, Principal projection - UK population in age groups. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/datasets/tablea21principalprojectionukpopulationinagegroups [Accessed June 2024]
  6. Nappi R and Kokot-Kierepa M. Climacteric 2012; 15: 36-44.
  7. Cumming G, et al. Menopause Int 2007; 13: 79-83.
  8. Parish S, et al. Int J Womens Health 2013; 5: 437-447.
  9. Nappi R, et al. Maturitas 2016; 91: 81–90.
  10. Kingsberg S, et al. J Sex Med 2013; 10(7): 1790–1799.
  11. Nappi R, et al. Maturitas 2013; 75: 373-379.
  12. Cancelo M, et al. Prog Obstet Ginecol 2016; 59(3): 141-150.
  13. Nappi, R et al. Minerva Ginecologica 2017; 69(4): 370-80.
  14. Nappi R, et al. Climacteric 2016; 19: 188-97.
  15. NICE. Menopause: diagnosis and management. NICE guideline [NG23] November 2015. https://www.nice.org.uk/guidance/ng23/evidence/full-guideline-pdf-559549261 [Accessed June 2024].
  16. Vagifem Summary of Product Characteristics.
  17. Ovestin Summary of Product Characteristics.
  18. Estring Summary of Product Characteristics.
  19. Nappi R, et al. Gynecol Endocrinol 2016; 32(8): 602–606.
  20. Goldstein S, et al. Climacteric 2014; 17: 173-182.
  21. Bachman G, et al. Clin Pract Sexuality 1991; 7: 25-32.
  22. Huang A, et al. Menopause 2015; 22(2): 144-154.
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