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Estring (Estradiol) 7.5 microgram/24 hours Vaginal Ring

Estring (Estradiol) 7.5 microgram/24 hours Vaginal Ring

Estring

Pharmaceutical Product
  • Licensed in the UK as ESTRING 7.5 microgram/24 hours vaginal delivery system with MHRA Marketing Authorisation (e.g. PL 00057/1424).
  • Prescription Only medicine (POM) regulated under UK human medicines legislation.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile and solid medicinal products.
  • Supported by an approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
Local vaginal oestrogen HRT (estradiol vaginal ring)

Description

Estring (Estradiol) 7.5 microgram/24 hours Vaginal Ring is a prescription-only, local hormone replacement therapy (HRT) for postmenopausal women. Each slightly opaque silicone vaginal ring contains 2 mg estradiol hemihydrate (equivalent to 1.94 mg estradiol) and delivers an average of 7.5 micrograms of estradiol per 24 hours over 90 days. The ring is inserted into the upper third of the vagina, where it continuously releases a low dose of oestrogen directly to the vaginal tissues. By restoring local oestrogen levels, Estring helps treat symptoms of postmenopausal vaginal atrophy such as dryness, itching, soreness, discomfort during intercourse and an increased tendency to vaginal or urinary infections. Systemic estradiol exposure remains within the normal postmenopausal range, so it is intended for urogenital symptoms only and is not suitable for vasomotor symptoms or osteoporosis prevention. After 90 days, the ring must be removed and may be replaced with a new one if ongoing treatment is required, under medical supervision.

Bnefits

  • Provides continuous, low-dose local oestrogen delivery (7.5 micrograms estradiol per 24 hours for 90 days) directly to the vaginal tissues.
  • Effectively treats symptoms of postmenopausal vaginal atrophy such as dryness, itching, soreness, discomfort during sex and related urinary symptoms.
  • Local vaginal delivery results in very low and stable systemic estradiol levels within the postmenopausal range, minimising systemic hormone exposure compared with systemic HRT.
  • Convenient dosing: each ring remains in place for up to 90 days, reducing the need for daily applications of creams, tablets or pessaries.
  • Soft, flexible silicone ring design allows most women to insert and remove it themselves, and it is usually not felt once in place.
  • Does not require concomitant progestogen in most women, as systemic estradiol levels remain within the postmenopausal range (according to SmPC guidance).
  • Licensed, MHRA-regulated medicinal product with a defined safety profile and comprehensive SmPC and Patient Information Leaflet.
  • Can be an option for women who have difficulty inserting vaginal tablets, creams or pessaries, as insertion can be performed by a clinician if needed.

Indications

  • Treatment of atrophic vaginitis due to oestrogen deficiency in postmenopausal women (local urogenital symptoms of menopause).
  • Relief of vaginal symptoms such as dryness, irritation, itching, soreness and discomfort during intercourse associated with postmenopausal oestrogen deficiency.
  • Improvement of urogenital symptoms such as urinary urgency, dysuria and recurrent urinary infections when these are due to local oestrogen deficiency.
  • Use as part of hormone replacement therapy aimed specifically at local vaginal atrophy, not for systemic menopausal symptoms.

Composition

  • Active substance: Estradiol hemihydrate 2.0 mg per vaginal ring (equivalent to 1.94 mg estradiol), releasing an average of 7.5 micrograms estradiol per 24 hours for 90 days.
  • Excipients: Silicone elastomer Q7-4735A.
  • Excipients: Silicone elastomer Q7-4735B.
  • Excipients: Silicone fluid (as dispersing agent).
  • Excipients: Barium sulfate (radiopaque marker).

Formulation

  • Pharmaceutical form: Vaginal delivery system (silicone elastomer ring).
  • Slightly opaque silicone elastomer ring with a whitish core, containing a drug reservoir of estradiol hemihydrate.
  • Dimensions: outer diameter approximately 55 mm; cross-sectional diameter approximately 9 mm; core diameter approximately 2 mm.
  • Monolithic vaginal ring composed of silicone polymers with incorporated estradiol and barium sulfate.
  • Designed to release estradiol at an average rate of 7.5 micrograms per 24 hours over a period of 90 days.

Packaging

  • Each ring is individually packed in a heat-sealed rectangular pouch consisting of polyester, aluminium foil and low-density polyethylene, with a tear-off notch.
  • Individual pouch supplied in a cardboard carton containing one Estring vaginal ring and a Patient Information Leaflet.
  • Pack size used by the listed retailer: 1 x Estring vaginal ring (single ring pack).

Usage

  • For intravaginal use only; one ring is inserted into the upper third of the vagina and worn continuously for 90 days.
  • Insertion: with clean hands, compress the ring into an oval shape and gently push it upwards and backwards into the vagina as far as it will comfortably go; most women will not feel it once correctly positioned.
  • Removal: after 90 days (or earlier if advised), hook a finger through the ring and gently pull it downwards and forwards to remove.
  • Each ring should be worn continuously for 3 months and then removed; if ongoing therapy is required, a new ring should be inserted immediately after removal of the previous ring.
  • Treatment should be initiated and supervised by a healthcare professional who will assess suitability based on medical history and risk factors.
  • Therapy may begin at any time in postmenopausal women with established amenorrhoea or long intervals between spontaneous menses, or when switching from another HRT regimen according to medical advice.
  • The lowest effective dose and shortest duration of therapy should be used; the maximum recommended duration of continuous therapy is generally 2 years, with regular risk–benefit review.
  • Estring is usually left in place during sexual intercourse; if uncomfortable, it may be removed and rinsed in lukewarm water before being reinserted by the patient.
  • If the ring is expelled (e.g. during straining for bowel movements), it should be rinsed in lukewarm water and reinserted as soon as possible.
  • Patients should attend regular check-ups, including breast examinations and cervical screening as appropriate, while using Estring.
  • Used rings should be placed in the original pouch or a sealed plastic bag and disposed of safely in household waste; they must not be flushed down the toilet.

Contraindications

  • Known, past or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer).
  • Undiagnosed genital bleeding.
  • Untreated endometrial hyperplasia.
  • Current, previous or suspected venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism).
  • Active or recent arterial thromboembolic disease (e.g. myocardial infarction, stroke).
  • Acute liver disease or a history of liver disease where liver function tests have not returned to normal.
  • Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency) when systemic risk is considered clinically relevant.
  • Porphyria.
  • Known hypersensitivity to estradiol hemihydrate or to any of the excipients (silicone components, barium sulfate).
  • Pregnancy and breastfeeding.
  • Not recommended for use in children or premenopausal women.

Adverse Effects

  • Common local effects: vaginal discharge, increased vaginal secretions, vaginal itching or irritation, vaginal discomfort or pain, and urinary tract infections.
  • Local ring-related symptoms such as sensation of the ring, pressure on bladder or rectum, or ring expulsion or displacement, particularly during straining.
  • Abdominal or pelvic pain and cramps.
  • Vaginal candidiasis or other genital infections.
  • Breast tenderness, breast pain or breast enlargement, similar to other oestrogen therapies.
  • Irregular vaginal bleeding or spotting, especially at the beginning of therapy.
  • Systemic oestrogen-related adverse effects reported with HRT in general include increased risk of venous thromboembolism, stroke, endometrial hyperplasia/cancer (if systemically active oestrogen without adequate progestogen is used), and breast cancer; although systemic estradiol exposure with Estring is low, these class warnings still apply and must be considered.
  • Headache or migraine, mood changes (including depression or anxiety) and changes in libido have been reported with oestrogen therapies.
  • Allergic reactions such as rash, urticaria or pruritus; rarely more severe hypersensitivity reactions.
  • Oedema, weight changes or changes in triglyceride levels have been reported with oestrogen therapies.

Storage Conditions

  • Do not store above 25°C.
  • Store in the original heat-sealed pouch and outer carton until use to protect from moisture and light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the carton and pouch (EXP).
  • Do not use if the ring is discoloured, misshapen or the surface is not smooth.
  • After removal, place the used ring in the original pouch or a sealed plastic bag and dispose of it safely in household waste; do not flush down the toilet or dispose of in wastewater.

Duration

Each Estring ring is worn continuously for 90 days. If symptoms persist and continued therapy is appropriate, a new ring can be inserted for further 90-day cycles. The maximum recommended duration of continuous therapy is generally 2 years, with periodic clinical review to ensure that benefits continue to outweigh risks.

Onset

Symptom improvement usually begins within the first few weeks of treatment, with many women experiencing significant relief of vaginal atrophy symptoms within 2\u20133 weeks. Full benefit may require several weeks of continuous use.

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