Hormonal preparations

Topical oestrogens should be used in the smallest effective amount for the shortest duration to minimise systemic effects. Treatment should be evaluated after 12 weeks.

The BNF states that the risk of endometrial hyperplasia and carcinoma is increased when systemic oestrogens are administered alone for prolonged periods. The endometrial safety of long-term or repeated use of topical vaginal oestrogens is uncertain; treatment should be reviewed at least annually, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma.

Information on the safety of the following products can be found in the individual manufacturer's Summary of Product Characteristics, which state:

• For these products for vaginal application, the systemic exposure to oestrogen (estriol / estradiol) remains close to, or within, the normal postmenopausal range; it is not recommended to add a progestogen
• The risks of breast cancer, endometrial cancer, ovarian cancer, venous thromboembolism, stroke and coronary heart disease should be considered in case of long term or repeated use
• If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy

Most women will be able to comply with vaginal cream and this should be first choice.

These preparations may damage latex condoms and diaphragms – refer to individual manufacturer's Summary of Product Characteristics.

Formulary guidance on the management of menopause can be accessed here.

Estriol cream

• Vaginal cream 1mg/g, providing 0.5mg estriol per applicatorful (30 applications) (£4.45 = 15g)

Indications and dose

• Vaginal atrophy due to oestrogen deficiency in postmenopausal women
  • One applicator dose daily, at bedtime, for the first weeks (maximally 4 weeks), followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 application, at bedtime, twice a week) is reached. Local specialists may recommend alternative doses
• Preventing recurrent UTI in postmenopausal women (off label)
  • One applicator dose (0.5mg estriol) applied topically at night for 2 weeks then twice weekly

Notes

1. In order to prevent endometrial stimulation, the daily dose should not exceed 1 application (0.5 mg estriol) nor should this maximum dose be used for longer than several weeks (maximum 4 weeks)
2. Review treatment periodically to assess need for continued treatment

Estradiol vaginal tablet

• Vaginal tablet 10 micrograms (click here for preferred brand)

Indications

• Vaginal atrophy due to oestrogen deficiency in postmenopausal women

Dose

• Insert one tablet daily for 2 weeks, reducing to one tablet twice weekly

Notes

1. Interrupt treatment periodically to assess for continued treatment.
2. Where a preferred brand is recommended for a particular presentation, prescribing by brand helps ensure cost-efficient use of local NHS resources (see preferred brand link above).

Estradiol vaginal ring

• Vaginal ring 7.5 micrograms/24 hours (£31.42 = 1 ring (3 months treatment))

Indications and dose

• Vaginal atrophy due to oestrogen deficiency in postmenopausal women
  • Inserted into upper third of vagina and worn continuously; replace after 3 months; maximum duration of continuous treatment 2 years
• Preventing recurrent UTI in postmenopausal women (off label)
  • One ring (7.5 micrograms/24 hour) worn continuously for 12 weeks then replace, maximum duration of continuous treatment 36 weeks

Notes

1. Interrupt treatment periodically to assess for continued treatment.

Ospemifene

The routine commissioning of ospemifene (Senshio) is not accepted in Devon for the treatment of vulvar and vaginal atrophy (see Commissioning Policy for more information).

Prasterone

The routine commissioning of prasterone (Intrarosa) is not accepted in Devon for the treatment of vulvar and vaginal atrophy (see Commissioning Policy for more information).

Non-hormonal preparations

ReplensMD

• Intravaginal gel (£11.64 = 12 applicators)

Indications

• Symptomatic relief in women post-radiotherapy in whom alternative preparations have been unsuccessful

Dose

• One application three times a week, in the morning

Notes

1. Treatment is to be initiated by an appropriate consultant