Estriol vaginal cream 0.1%
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Vaginal cream containing estriol (0.1%).
Atrophic vaginitis - post-menopausal
Vaginitis - post menopausal (prior to vaginal surgery for prolapse)
Vaginitis in post-menopausal women (after vaginal surgery)
Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
Pre-surgery therapy for vaginal operations and during subsequent post-surgery convalescence.
Treatment of atrophic vaginitis associated with the menopause
1 application daily for up to 4 weeks.
Based on relief of symptoms, a gradual reduction should follow until a maintenance dose of 1 application twice a week is reached.
1 application daily to be started 2 weeks before the operation.
After surgery, therapy may be resumed 2 weeks after surgery at 1 application twice a week.
Additional Dosage Information
The daily dose should not exceed 1 application (0.5mg estriol) nor should this maximum dose be used for longer than several weeks (maximum 4 weeks) in order to prevent endometrial stimulation.
For estriol 0.1% vaginal cream, the systemic exposure of estriol remains close to the normal postmenopausal range when used in a twice weekly administration, it is not recommended to add a progestagen.
A missed dose should be administered as soon as remembered, unless it is more than 12 hours overdue. When over 12 hours, the dose should be skipped and the next dose should be administered at the normal time.
For intravaginal use.
The applicator containing the cream should be inserted deep into the vagina and the plunger should slowly be pushed down.
Abnormal liver function test
Acute hepatic disorder
Deep vein thrombosis
History of breast cancer
History of hormone dependent neoplasm
History of thromboembolic disorder
Hormone dependent neoplasm
Recent arterial thromboembolic disorder
Uncontrolled endometrial hyperplasia
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of breast cancer
Patients over 65 years
Predisposition to thromboembolic disease
Fibrocystic breast disorder
History of endometrial hyperplasia
History of endometriosis
Sickle cell disease
Systemic lupus erythematosus
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Treat vaginal infections before initiation of therapy
Contains cetostearyl alcohol: may cause irritation
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.
Current data indicate that there is no increase in risk of breast cancer in women with no history of breast cancer taking low dose vaginally applied oestrogen. It is unknown if low dose vaginal oestrogens stimulate recurrence of breast cancer.
The presence of a personal or strong family history of 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 increased 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.
Pregnancy and Lactation
Estriol vaginal cream is contraindicated during pregnancy.
The manufacturer does not recommend using estriol during pregnancy. Studies indicate no increased risk of teratogenic or foetotoxic effects.
Estriol vaginal cream is contraindicated during breastfeeding.
The manufacturer does not recommend using estriol during breastfeeding. Estriol is excreted in breast milk and may decrease milk production.
Aggravation of porphyria
Deep vein thrombosis (DVT)
Increase in plasma triglyceride concentration
Increased cervical secretion
Increased frequency of micturition
Increased risk of breast cancer
Increased risk of endometrial cancer
Increased risk of ovarian cancer
Increased size of uterine fibroids
Liver function disturbances
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.
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-I-antitrypsin, ceruloplasmin).
Last Full Review Date: March 2020
Summary of Product Characteristics: Ovestin 1mg Cream. Aspen. Revised November 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 February 2020.
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