Estriol
Indications for use
- Treatment of vaginal symptoms of genitourinary syndrome of menopause due to oestrogen deficiency (such as vaginal dryness, soreness, itching, burning and uncomfortable sex)
Age
- Postmenopausal women aged 50 years and above who have not had a period for at least 1 year
Dose/Directions
- Initial dose: one application (0.5 g of cream, delivering 0.5 mg estriol) intravaginally once daily for 2 weeks
- Maintenance dose: one application twice a week
- Apply using the calibrated applicator supplied; insert high into the vagina, preferably at bedtime
Duration
- Symptoms that do not start to improve or worsen after 3 months of treatment – refer to GP
- A risk–benefit assessment should be undertaken at every pharmacy visit for resupply. HRT should only be continued as long as the benefit outweighs the risk
Contra-indications/referral criteria
- Hypersensitivity to estriol or any of the excipients
- Known, past or suspected breast cancer or oestrogen-dependent malignant tumours (e.g. endometrial or ovarian cancer)
- Undiagnosed genital bleeding
- Untreated endometrial hyperplasia
- Previous or current venous thromboembolism (DVT, PE)
- Known thrombophilic disorders
- Active or recent arterial thromboembolic disease (e.g. angina, MI, stroke)
- Active liver disease or a history of liver disease where liver function tests have failed to return to normal
- Porphyria
- Untreated vaginal infection, vulval dermatoses or rash, severe vaginal itching
- Women using systemic HRT – should consult their doctor about their overall HRT regimen before adding Ovesse
Examples of drug interactions
- Clinically significant interactions are unlikely due to the local vaginal route of administration
- May interact with other vaginal products (e.g. vaginal antifungals); allow a suitable interval between applications if using both
Side-effects
- Breast tenderness or pain, nausea, headache
- Vaginal bleeding or spotting, excessive cervical mucus, vaginal discomfort (burning, itching) – usually transient at the start of treatment
Other pertinent information
- Available as Ovesse 1 mg/g vaginal cream – the first and only vaginal oestrogen cream available without prescription in the UK (reclassified POM to P in 2024)
- See also the Estradiol (Gina) page – Gina 10 microgram vaginal tablets are the other OTC vaginal HRT product (a tablet rather than a cream)
- The pharmacist checklist at supply should cover: confirmation of postmenopausal status, symptom assessment, medical history (particularly breast cancer, VTE, undiagnosed bleeding), and discussion of benefits and risks
- Ovesse contains cetyl palmitate and cetyl alcohol which may cause local skin irritation in some patients; it may also weaken latex condoms and diaphragms
- Reclassified POM→P: 2024