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Topical HRT

Urogenital atrophy is a common result of the menopause but may present for the first time more than 10 years after the last menstrual period (LMP). Typically presenting symptoms include vaginal dryness, discharge, superficial dysparunia, urinary symptoms or recurrent UTIs. The vulva and vagina look thin, dry and pale.

Creams containing oestrogen (topical or vaginal HRT) may be applied on a short-term basis to alleviate this condition.
The advantage of this route of administration is that oestrogen is delivered directly to oestrogen-depleted tissues with similar efficacy to oral oestrogen but with limited systemic absorption and reduced risk of side-effects. Systemic absorption is low but not negligible – in a double blind, randomised, parallel group study 74% of women using 25 micrograms daily of 17-β estradiol daily and 96% of those using 10 micrograms showed very low systemic absorption1.
Alternatives include:

  • Vaginal lubricants if main symptoms are pain on intercourse due to dryness
  • Bioadhesive, non-hormonal preparations eg. Replens®
  • Systemic HRT if flushing and night sweats are predominant.
Indications2
  • Short-term treatment of menopausal atrophic vaginitis. Good evidence for efficacy. 3
  • Prior to prolapse repair surgery in postmenopausal women with evidence of epithelial atrophy.
  • Treatment of urinary symptoms4 – there is some evidence that recurrent UTIs in post-menopausal women can be prevented by oestrogen replacement but no trial data as to suitable dosing and duration of treatment. Similarly urge incontinence may be improved by low-dose vaginal oestrogens.
  • Treatment of labial adhesions in girls.5
Contraindications2

As for systemic HRT

  • Oestrogen-dependent cancers
  • Past history of breast cancer – evidence conflicting but seek specialist advice6
  • Active or recent cardiovascular disease
  • Recurrent venous thromboembolic disease (unless on anticoagulant therapy)
  • Liver disease with deranged LFTs including Dubin-Johnson and Rotor syndromes
  • Untreated endometrial hyperplasia or undiagnosed abnormal vaginal bleeding
  • Porphyria
Cautions2
  • Migraine
  • Diabetes and other risk factors of heart disease
  • History of breast nodules or fibrocystic disease of the breast (increased risk of breast cancer, monitor closely)
  • Risk factors for oestrogen-dependent tumours (eg. breast cancer in first degree relatives)
  • Uterine fibroids – may increase in size
  • Risk factors predisposing to thromboembolism (eg antiphospholipid syndrome)
Side-effects2
  • Systemic absorption – oestrogen-related side-effects eg. breast tenderness
  • Endometrial hyperplasia – CSM guidance states that topical oestrogens may be used in those with intact uteruses for up to 3 months without considering the addition of a progestogen to prevent endometrial stimulation7. Conjugated oestrogens are more likely to have an effect on oestrogen levels and endometrial stimulation than other oestrogen preparations and so should be avoided in women with an intact uterus or used with progestogen for 10-14 days at the end of each cycle6. To date, studies have found no significant association between the use of low-potency unopposed vaginal oestrogens and the risk of endometrial cancer7. CSM advice is that the safety of long term use or repeated use of topical oestrogens is uncertain7 and caution should be applied but expert consensus suggests that the addition of a progestogen is not always necessary for endometrial protection for preparations that have low systemic bioavailability6. Vaginal rings are licensed for 2 years' continuous use without the need for progestogen replacement6
  • Local irritation
Initiating and monitoring treatment6
  • Establish no contra-indications to oestrogen therapy – if present avoid prescribing topical oestrogens or seek specialist advice as some systemic absorption occurs.
  • Breast and pelvic examination are only required if indicated by current personal history or family history.
  • Use the lowest effective dose to minimise systemic absorption (eg. pessaries or creams daily for the first 2 weeks then twice weekly)
  • Use preparations that have low systemic bioavailability – PRODIGY guidelines advise against Premarin as systemic absorption of oestrogen is significantly higher with this product. Efficacy of creams, pessaries, tablets and vaginal rings appears equal3 As a treatment choice, women appear to favour the estradiol-releasing vaginal ring3
  • Maximal benefit usually occurs after 1-3 months but may take up to a year
  • Treatment should be reviewed regularly with efforts to reduce or discontinue at 3-6 month intervals with re-examination. Where used over a longer-term (>3-6months), addition of a progestogen for those with intact uteruses should be considered (but see above).
  • Interrupt treatment at least annually to reassess the need for continued treatment.
  • If bleeding or spotting occurs at any time, refer to a gynaecologist for exclusion of endometrial malignancy.
Estriol- containing products
  1. Ortho-Gynest® 0.01% vaginal cream (80g) One applicator = 500 micrograms of estriol
  2. Ovestin® 0.1% vaginal cream (15g) One applicator=500 micrograms of estriol
  3. Orthogynest® 500 microgram pessaries (30 pessaries)
Estradiol-containing products
  1. Vagifem® 25 microgram pessaries (30 pessaries)
  2. Estring® 2 mg vaginal ring (releases approximately 7.5 micrograms estradiol/24 hours) – insert high into the vagina and wear continuously. Replace every 3 months.
Conjugated equine oestrogens
  1. Premarin® 625migrograms/g (42.5g)
Patient Advice
  • Report any PV bleeding
  • Longer term safety of these drugs is uncertain at the moment – safest to limit treatment to lowest doses and shortest durations to control symptoms and regularly review situation.


Document references
  1. Notelovitz M, Funk S, Nanavati N, et al; Estradiol absorption from vaginal tablets in postmenopausal women.; Obstet Gynecol. 2002 Apr;99(4):556-62. [abstract]
  2. British National Formulary British Medical Association and Royal Pharmaceutical Society of Great Britain. London.
  3. Suckling J, Lethaby A, Kennedy R; Local oestrogen for vaginal atrophy in postmenopausal women.; Cochrane Database Syst Rev. 2003;(4):CD001500. [abstract]
  4. Menopause, Clinical Knowledge Summaries (January 2008)
  5. BNF for Children
  6. Prodigy Quick Reference Guidelines : Menopause - Urogenital atrophy Issued July 2005, viewed Jan 2006
  7. CSM Reminder: Gastrointestinal toxicity and NSAIDS. Current Problems in Pharmacovigilance.(2003) 29, 8-9

Internet and further reading AcknowledgementsEMIS is grateful to Dr Chloe Borton for writing this article. The final copy has passed scrutiny by the independent Mentor GP reviewing team. ©EMIS 2008.
DocID: 473
Document Version: 3
DocRef: bgp25198
Last Updated: 27 May 2007
Review Date: 26 May 2008




















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