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Estriol vaginal cream 0.01%


Vaginal cream containing estriol (0.01%).

Drugs List

  • estriol 0.01% vaginal cream
  • Therapeutic Indications


    Atrophic vaginitis - post-menopausal
    Kraurosis vulvae- post menopausal
    Pruritus vulvae

    Hormone replacement therapy for the treatment of atrophic vaginitis and kraurosis in post-menopausal women.

    Treatment of pruritus vulvae and dyspareunia when associated with atrophic vaginal epithelium.



    Treatment may begin any time after the manifestation of atrophic vaginitis or associated symptoms, such as dyspareunia or pruritus.

    The lowest dose that will control symptoms should be used and treatment should be discontinued as soon as possible. The discontinuation of therapy should be considered at 3 to 6 monthly intervals following physical examination.

    Initial dose:
    0.5mg estriol (one applicator full of vaginal cream) daily.

    Maintenance dose
    0.5mg estriol (one applicator full of vaginal cream) twice a week may be used when the vaginal mucosa has been restored.


    For intravaginal use.

    The applicator of cream should be inserted high into the vagina, preferably in the evening.


    Abnormal liver function test
    Acute hepatic disorder
    Breast cancer
    Deep vein thrombosis
    History of breast cancer
    History of hormone dependent neoplasm
    History of thromboembolic disorder
    Hormone dependent neoplasm
    Myocardial infarction
    Pulmonary embolism
    Recent arterial thromboembolic disorder
    Thromboembolic disorder
    Thrombophilic disorder
    Uncontrolled endometrial hyperplasia
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Family history of breast cancer
    Patients over 65 years
    Predisposition to thromboembolic disease
    Prolonged immobilisation
    Recent surgery
    Recent trauma
    Severe headache
    Cardiac impairment
    Diabetes mellitus
    Endometrial hyperplasia
    Epileptic disorder
    Fibrocystic breast disorder
    Hepatic adenoma
    Hepatic disorder
    Hepatic impairment
    History of endometrial hyperplasia
    History of endometriosis
    Malignant melanoma
    Multiple sclerosis
    Renal impairment
    Sickle cell disease
    Systemic lupus erythematosus
    Uterine fibroids

    Assess family medical history prior to commencing treatment
    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Contains arachis (peanut oil), soya or soya derivative
    Do breast & pelvic exam. before & during treatment if clinically indicated
    Exclude pregnancy prior to initiation of treatment
    Abnormal and/or irregular bleeding should be investigated
    Advise patients of risks/benefits & review need for treatment regularly
    Discontinue treatment if patient develops seizures
    Monitor hepatic function in patients with history of hepatic disease
    Advise patient that changes in their breasts should be reported to Dr/nurse
    Advise patient to contact a doctor if symptoms of thromboembolism develop
    Discontinue at the onset of severe depression
    Uterine fibroids may increase in size
    May affect results of some laboratory tests
    Discontinue 4 - 6 weeks before major surgery
    Advise patient to seek advice at first indications of pregnancy
    Discontinue at first signs of thrombophlebitis or thromboembolism
    Discontinue if abnormal neurological signs develop
    Discontinue if cholestasis develops
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if significant rise in blood pressure occurs
    Discontinue if sudden pain in the chest occurs
    Discontinue if symptoms due to endometriosis are exacerbated
    Discontinue in the event of a prolonged period of immobilisation
    Advise patient not to take St John's wort concurrently
    Female: Not for contraception.Use non-hormonal contraception, if required
    Male & female: Damages latex condoms and diaphragms
    Advise patient of increased risk of breast cancer vs benefits of HRT

    Hormone replacement therapy (HRT) should only be considered for patients whose symptoms adversely affect quality of life. An annual careful appraisal of the risks and benefits should be undertaken. When carrying out initial medical examinations of patients, ensure that investigations (including appropriate imaging tools, e.g. mammography) are carried out in accordance with currently accepted screening practices.

    There is an increased risk of breast cancer in women currently or recently using Hormone Replacement Therapy (HRT). The risk of breast cancer increases with the duration of treatment and returns to normal after 5 years of stopping treatment.

    The presence of a personal or strong family history of recurrent thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. HRT treatment should be stopped until a definitive diagnosis has been made or anticoagulant treatment initiated. Use of systemic HRT is associated with an increase risk of developing venous thromboembolism (VTE), the risk is more likely within the first year of HRT.

    In all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery. When prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended. Treatment can be resumed when the patient is completely mobilised.

    Estriol vaginal cream contain arachis (peanut) oil and should be avoided by patients with peanut allergy. There is a possible relationship between peanut and soya allergy therefore patients allergic to soya should also avoid this formulation.

    Pregnancy and Lactation


    Estriol vaginal cream is contraindicated during pregnancy.

    The manufacturer does not recommend using estriol vaginal cream during pregnancy. Studies indicate no increased risk of teratogenic or foetotoxic effects.


    Estriol vaginal cream is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst using estriol vaginal cream.

    Side Effects

    "Spotting" bleeding
    Abdominal pain
    Aggravation of porphyria
    Breakthrough bleeding
    Breast pain
    Deep vein thrombosis (DVT)
    Endometrial hyperplasia
    Erythema multiforme
    Erythema nodosum
    Fluid retention
    Gallbladder disease
    Hypersensitivity reactions
    Increase in plasma triglyceride concentration
    Increased frequency of micturition
    Increased risk of breast cancer
    Increased risk of endometrial cancer
    Increased risk of ovarian cancer
    Increased size of uterine fibroids
    Leg pain
    Liver function disturbances
    Pelvic pain
    Peripheral oedema
    Premenstrual symptoms
    Pulmonary embolism
    Skin reactions
    Thromboembolic disorders
    Vaginal candidiasis
    Vaginal discharge
    Vascular purpura

    Effects on Laboratory Tests

    Hormone replacement therapy, especially oestrogen-progestogen combined treatment may increase the density of mammographic images and adversely effect the detection of breast cancer.

    The use of oestrogen may influence the laboratory results of certain endocrine tests and liver enzymes.

    Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone. Oestrogens may also be increase corticoid binding globulin (CBG) and sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biological active hormone concentrations are unchanged.

    Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrysin, ceruloplasmin). With vaginal administration, stimulation of the liver by the first-pass effect us avoided and thus, transvaginal oestrogens might affect hormone binding proteins and other serum proteins produced by the liver less than oral hormones.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2020

    Reference Sources

    Summary of Product Characteristics: Estriol 0.01 % w/w cream. Marlborough Pharmaceuticals Ltd. Revised October 2019.

    NICE Evidence Services Available at: Last accessed: 18 February 2020

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