HRT - topical vaginal

Oestrogen deficiency of the menopause often causes significant effects on the vagina and bladder, leading to vaginal dryness, and discomfort during sex. This may have an adverse effect on sexual interest, response, sexual function, relationships and quality of life, as well as bladder problems.

Surveys have shown that 45% to 63% of postmenopausal women have experienced vulvovaginal symptoms, most commonly vaginal dryness.¹ However, symptoms are under-reported and under-treated.

Vaginal oestrogen preparations²

Low-dose vaginal oestrogen can be used in different forms, depending on the woman's preferences:

• Vaginal tablet (Vagifem®).

• Vaginal cream (Ovestrin® or Gynest®).

• Vaginal gel (Blissel®).

• Vaginal pessary (Imvaggis®).

• Vaginal ring (Estring®).

A progestogen is not needed for endometrial protection, as systemic absorption of vaginal oestrogen is minimal.

Vaginal oestrogen regimens²

Vaginal oestrogen therapy regimens depend on the vaginal preparation used:

• One vaginal tablet daily for two weeks, then reduced to one vaginal tablet twice weekly.

• One applicatorful daily for 3-4 weeks, then reduced to one applicatorful twice weekly, to be applied at bedtime, for cream and gel preparations.

• One pessary daily for three weeks, then reduced to one pessary twice weekly, to be inserted at bedtime.

• One vaginal ring inserted into the upper third of the vagina and worn continuously, to be replaced at three months. Maximum duration of continuous treatment is two years.

Vaginal oestrogen preparations may be required long-term, but regular attempts to stop treatment, such as annually, can be made.

Indications

• There is good evidence for the efficacy of vaginal HRT in the treatment of menopausal atrophic vaginitis.³

• Vaginal symptoms are improved, vaginal atrophy and pH decrease and there is improved epithelial maturation with vaginal oestrogen preparations compared to placebo or non-hormonal gels.⁴

• The different preparations of vaginal HRT (creams, tablets and the estradiol vaginal ring) all appear equally effective for treating vaginal atrophy.

• Vaginal HRT is sometimes used prior to prolapse repair surgery in postmenopausal women with evidence of epithelial atrophy.

• Vaginal oestrogens can be really effective in patients with urinary urgency, frequency or nocturia, urinary incontinence and recurrent UTIs.⁵

• Urge incontinence may be improved by low-dose vaginal oestrogens.
  Topical vaginal oestrogens can be used to treat labial adhesions in girls.

Genitourinary syndrome of menopause

Oestrogen deficiency of the menopause often causes significant effects on the vagina and bladder, leading to vaginal dryness, and discomfort during sex. This may have an adverse effect on sexual interest, response, sexual function, relationships and quality of life, as well as bladder problems. Surveys have shown that 45% to 63% of postmenopausal women have experienced vulvovaginal symptoms, most commonly vaginal dryness.¹ However, symptoms are under-reported and under-treated.

The term genitourinary syndrome of menopause (GSM) is now usually used instead of vulvovaginal atrophy or atrophic vaginitis.⁶

For urogenital symptoms (genitourinary syndrome of menopause):²

• Offer low-dose vaginal oestrogen first-line and continue treatment for as long as needed to relieve symptoms. NB: some women on systemic HRT may also benefit from additional low-dose vaginal oestrogen.

• If a low-dose preparation does not relieve symptoms sufficiently, consider seeking specialist advice about increasing the dose.

• If low-dose vaginal oestrogen is not tolerated or is contra-indicated, consider a trial of oral ospemifene (a selective oestrogen receptor modulator) if there are moderate-to-severe symptoms and no contra-indications, depending on local prescribing guidelines.

• Advise that vaginal moisturisers and lubricants can be used alone or in addition to vaginal oestrogen preparations.

Contra-indications

The only contra-indications to use of topical oestrogens are active breast cancer and also undiagnosed vaginal or uterine bleeding.¹ They are otherwise safe. The amount systemically absorbed is very low.⁷

Side-effects and risks

• Some women (rarely) experience local irritation with the use of topical oestrogens.

• The creams may damage latex condoms and diaphragms; women using these types of contraception should be advised to use either vaginal tablets or the vaginal ring.

Vaginal oestrogen is not associated with an increased risk of breast cancer.⁸

Initiating and monitoring treatment

• Establish that there are no contra-indications to vaginal oestrogen therapy - if present, avoid prescribing topical oestrogens or seek specialist advice.

• Use the lowest effective dose to minimise systemic absorption - eg, creams daily for the first two weeks and then reducing to twice weekly.

• Use preparations that have low systemic bioavailability. Efficacy of creams, tablets and vaginal rings is similar.

• Women's individual preference for type of preparation needs to be taken into account. It is common to have more vaginal discharge with creams, which may be an advantageous side-effect in sexually active women.

• Endometrial hyperplasia or adenocarcinoma are extremely rare after long-term use.¹

• Low-dose vaginal oestrogen does not need to be given with systemic progestogens.

• Most women will have relief of their symptoms after about three weeks of treatment. Maximal benefit usually occurs after 1-3 months but may take up to a year.

• Vaginal oestrogen should be offered to women with symptoms (including those on systemic HRT) and then continued for as long as needed to relieve these symptoms.⁹

• The following should be explained to women:⁹

  • Symptoms often return when the treatment is stopped.

  • Adverse effects from using vaginal oestrogen are very rare.

  • Any abnormal vaginal bleeding should be reported to their GP.

If symptoms have not improved with hormonal treatment, then another underlying cause of for the symptoms should be considered (eg, dermatitis, vulvodynia).

Alternative treatments

• Non-hormonal moisturisers are a beneficial alternative for those with few or minor atrophy-related symptoms.⁵

• Vaginal lubricants if the main symptoms are pain due to dryness on intercourse.

• They are bioadhesive, non-hormonal preparations.

• Systemic HRT should be considered if flushing and night sweats are also present.

• Systemic HRT fails to resolve vaginal symptoms in 10% to 15% of women and additional vaginal oestrogen may then be needed.¹⁰