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Ovestin (Estriol) 0.1% Cream 15g

Ovestin (Estriol) 0.1% Cream 15g

Ovestin

Hormone Replacement Therapy (HRT)
  • MHRA Authorised prescription medicine containing estriol 1 mg/g vaginal cream (0.1%).
  • Manufactured in compliance with Good Manufacturing Practice (GMP) for medicinal products.
  • Supplied with a calibrated applicator that meets relevant medical device/CE Marking requirements in applicable markets.
  • Listed in national and regional formularies as a recognised topical oestrogen preparation for postmenopausal vaginal atrophy, where approved.
Vaginal oestrogen cream for postmenopausal vaginal atrophy

Description

Ovestin (Estriol) 0.1% Cream 15g is a prescription-only vaginal hormone replacement therapy (HRT) containing estriol 1 mg per gram of cream (0.1%). It is mainly prescribed to relieve symptoms of postmenopausal vaginal atrophy and genitourinary syndrome of menopause, such as dryness, itching, irritation, and painful intercourse caused by oestrogen deficiency after menopause. Applied intravaginally with a calibrated applicator, the cream delivers estriol locally to restore the vaginal lining, improve elasticity and lubrication, and normalise vaginal pH and flora, while limiting systemic exposure. Ovestin cream may also be used before or after vaginal surgery in postmenopausal women to support wound healing, and in some cases to assist with the assessment of atrophic cervical smears. Treatment and duration should always be determined and monitored by a healthcare professional.

Bnefits

  • Provides local oestrogen replacement directly to the vaginal tissues with limited systemic absorption.
  • Relieves postmenopausal symptoms of vaginal atrophy such as dryness, itching, burning, irritation and dyspareunia (painful intercourse).
  • Helps restore the thickness, elasticity and lubrication of the vaginal epithelium.
  • Supports normalisation of vaginal pH and flora, which may reduce susceptibility to irritation and infections.
  • Can be used around the time of vaginal surgery in postmenopausal women to support wound healing.
  • Lower overall hormone levels than systemic HRT because the cream is applied locally and at a low dose.
  • Well-established safety and efficacy profile for the treatment of postmenopausal vaginal symptoms.

Indications

  • Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women (for example vaginal dryness, burning, itching, irritation and pain during intercourse).
  • Relief of genitourinary syndrome of menopause (GSM) where local oestrogen therapy is appropriate.
  • Pre-operative therapy before vaginal surgery in postmenopausal women to improve the condition of the vaginal tissues.
  • Post-operative therapy after vaginal surgery in postmenopausal women to support healing, as advised by a specialist.
  • Adjunctive use as a diagnostic aid in the assessment of atrophic cervical smears in postmenopausal women, where recommended by a clinician.

Composition

  • Active ingredient: Estriol 1 mg per gram of cream (0.1%).
  • Excipients: Chlorhexidine hydrochloride.
  • Excipients: Eutanol G (octyldodecanol).
  • Excipients: Cetyl palmitate.
  • Excipients: Glycerol.
  • Excipients: Cetyl alcohol.
  • Excipients: Stearyl alcohol.
  • Excipients: Polysorbate 60.
  • Excipients: Sorbitan monostearate.
  • Excipients: Lactic acid.
  • Excipients: Sodium hydroxide (for pH adjustment).
  • Excipients: Purified water.

Formulation

  • Pharmaceutical form: Vaginal cream.
  • Strength: 1 mg estriol per gram of cream (0.1%).
  • One applicatorful (up to the marked ring) corresponds to 0.5 g cream containing 0.5 mg estriol.
  • Appearance: White, smooth cream of homogeneous consistency.
  • Route of administration: Intravaginal via a calibrated applicator.

Packaging

  • 15 g collapsible aluminium tube of vaginal cream.
  • Tube fitted with a polyethylene screw cap.
  • Supplied with a reusable, calibrated vaginal applicator.
  • Packed in a cardboard carton with a patient information leaflet.

Usage

  • For intravaginal use only; do not swallow.
  • Usual starting regimen for vaginal atrophy: insert one applicatorful of cream (0.5 g containing 0.5 mg estriol) into the vagina once daily, preferably at bedtime, for 2–3 weeks (up to a maximum of 4 weeks) or as directed by the prescriber.
  • After the initial daily phase, the dose is usually reduced to a maintenance regimen, such as one applicatorful twice weekly, according to symptom control and medical advice.
  • For pre-operative therapy for vaginal surgery: one applicatorful of cream once daily for 2 weeks before the operation, following the surgeon’s or prescriber’s instructions.
  • For post-operative therapy: restart after a post-surgery interval (commonly at least 2 weeks) using one applicatorful twice weekly or as directed by the specialist.
  • To use the applicator, screw it onto the tube, gently squeeze the tube to fill the applicator up to the marked ring, detach the applicator, insert it deeply into the vagina while lying on the back with knees slightly bent, and then slowly depress the plunger to release the cream.
  • Clean the applicator after each use according to the leaflet instructions (usually by rinsing with warm water and allowing to dry); do not use hot water or detergents and do not boil.
  • If a dose is missed and it is within about 12 hours of the usual time, apply it as soon as remembered; if more than 12 hours have passed, skip the missed dose and continue with the next scheduled dose. Do not use two doses on the same day.
  • Use the lowest effective dose for the shortest duration needed to relieve symptoms, with regular review by a healthcare professional.

Contraindications

  • Known, past or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours (for example endometrial carcinoma).
  • Undiagnosed genital bleeding.
  • Untreated endometrial hyperplasia.
  • Current or previous venous thromboembolism (for example deep vein thrombosis or pulmonary embolism).
  • Active or recent arterial thromboembolic disease, such as angina, myocardial infarction or stroke.
  • Acute liver disease or a history of liver disease as long as liver function tests have not returned to normal.
  • Known thrombophilic disorders where oestrogen therapy is contraindicated, unless specifically assessed as safe by a specialist.
  • Porphyria or other oestrogen-sensitive porphyrias where contraindicated.
  • Known hypersensitivity to estriol or to any of the excipients (for example chlorhexidine or cetyl/stearyl alcohols).
  • Pregnancy or breastfeeding (not indicated for use in these populations).

Adverse Effects

  • Local vaginal irritation, burning, itching or discomfort at the application site.
  • Increased vaginal discharge.
  • Spotting or breakthrough bleeding, especially during the first months of treatment.
  • Breast tenderness or breast discomfort.
  • Abdominal pain or cramps.
  • Headache or migraine.
  • Nausea or feeling sick.
  • Oedema (fluid retention or swelling).
  • Skin reactions such as rash, pruritus or urticaria.
  • Rarely, venous thromboembolic events (for example deep vein thrombosis, pulmonary embolism) associated with oestrogen exposure.
  • Rarely, arterial thromboembolic events (for example stroke, myocardial infarction).
  • Long-term inappropriate use or high-dose use may increase the risk of endometrial hyperplasia or carcinoma; this risk is minimised by correct low-dose local use and regular medical review.

Storage Conditions

  • Store below 25°C.
  • Do not freeze.
  • Keep the tube tightly closed when not in use.
  • Store in the original carton to protect from light where applicable.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the tube and carton; return any unused medicine to a pharmacist for safe disposal.

Duration

Initial daily treatment is typically 2\u20133 weeks (up to a maximum of 4 weeks), followed by a long-term maintenance regimen such as twice-weekly application as long as symptoms persist and the benefit outweighs the risk. The ongoing need for treatment should be reviewed regularly (commonly every 3\u20136 months) by a healthcare professional.

Onset

Local symptom relief often begins within a few days of starting therapy, with maximum improvement generally achieved within several weeks, typically around 2\u20134 weeks of regular use.

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