Estradiol
Indications for use
- Gina 10 microgram estradiol vaginal tablets are indicated for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency
Age
- Postmenopausal women aged 50 years and above who have not had a period for at least 1 year
Dose/Directions
- Initial dose: one vaginal tablet (10 micrograms) daily for two weeks. Maintenance dose: one vaginal tablet twice a week
- Gina will be available as a single pack size of 24 tablets which includes the two separate dosing instructions
- Each pack will provide up to 3 months treatment: 7 weeks of treatment for women using the product for the first time (i.e. the initial dose followed by the maintenance dose), or 12 weeks of treatment for women being supplied with the product on subsequent occasions (i.e. using only the maintenance dose) or those patients who are starting on a maintenance dose (e.g. because they are switching from another local oestrogen therapy)
- If the patient takes a treatment break from using Gina, she should start again on the dose most suitable to the symptoms i.e. if bothersome symptoms have returned, the patient should begin on the starting dose, otherwise they can continue on the maintenance dose
- The product literature states that women with symptoms that do not start to improve or worsen after 3 months of treatment, should be referred to their doctor. If Gina does not relieve symptoms adequately, advice from a doctor should be sought. The product literature states that a risk-benefit analysis should be undertaken at every pharmacy visit in every case for resupply. HRT should only be continued as long as the benefit outweighs the risk
Contra-indications/referral criteria
- Undiagnosed genital bleeding
- Known, past, or suspected endometrial cancer
- Untreated endometrial hyperplasia
- Patients with an intact uterus who have previously been treated with unopposed systemic oestrogens
- Vulval dermatoses or a vulval rash or severe vaginal itching
- Current vaginal infection prior to starting treatment
- Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast cancer, ovarian cancer)
- Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction, ischaemic stroke)
- Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)
- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
- Porphyria
- Hypersensitivity to any of the ingredients
The following patients should consult their doctor before treatment initiation
- Women with a history of endometriosis unless the patient has previously been prescribed vaginal oestrogens and her health status is unchanged since her last prescription, and she has no recent symptoms of endometriosis
- Endometrial hyperplasia unless the patient has previously been prescribed vaginal oestrogens and her health status is unchanged since her last prescription, or she has had a hysterectomy
- Women receiving hormonal therapy, including systemic formulations, unless she has previously received a prescription for a concurrent vaginal oestrogen product and her health status is unchanged since her last prescription
- Women switching to Gina from another vaginal oestrogen product who have used their current vaginal oestrogen product for less than 3 months, or been using their vaginal oestrogen product at the recommended dose and are experiencing bothersome symptoms
- Uterine fibroids (leiomyoma)
- Risk factors for thromboembolic disorders
- Risk factors for oestrogen-dependent tumours, e.g. 1st degree heredity for breast cancer
- Hypertension
- Liver disorders (e.g. liver adenoma)
- Diabetes mellitus with or without vascular involvement
- Cholelithiasis
- Migraines or (severe) headache
- Systemic lupus erythematosus (SLE)
- Epilepsy
- Asthma
- Otosclerosis
Examples of drug interactions
- The product literature states that it is unlikely that any clinically relevant drug interactions will occur with Gina. However, interactions with other locally applied vaginal treatments should be considered
Side-effects
- The most common side effects are: abdominal pain, vaginal discharge, vaginal discomfort and vaginal bleeding
- Serious side effects to low dose vaginal estradiol are rare
- Therapy should be discontinued, and advice sought from a doctor if the patient experiences: new onset of vaginal bleeding or spotting, new onset of vaginal itching, vaginal infection not adequately treated by a pharmacy treatment, symptoms of endometriosis
- Prompt advice should also be sought from a doctor if there is: signs of jaundice or deterioration in liver function, a significant increase in blood pressure, new onset of migraine-type headache or pregnancy
Other pertinent information
- Explain it gradually releases a low controlled dose of oestrogen which helps to restore the vaginal wall thus relieving symptoms. However vaginal atrophy is chronic and progressive, so symptoms are most likely to return if treatment is stopped
- When to expect to see an improvement (there may be some improvement before 3 months, but usually a significant improvement is not seen until after 3 months of treatment) and when to seek medical attention
- Explain how to use the applicator and to use the chart in the PIL to help remember when to use Gina
- Explain what to do if the patient misses a dose
- Tell the patient to inform her GP that she has started using Gina at her next routine appointment
- Ask her to return to the pharmacy when she finishes her first pack (7 weeks) and every 3 months thereafter. Exception is for those patients who are starting on a maintenance dose (e.g. switching from another local oestrogen therapy) as their first review/return to the pharmacy is after 3 months rather than after 7 weeks
- Ask her to report any new symptoms
- Provide general advice (well-woman advice) for peri-menopause and menopause includes having a healthy diet (including calcium-rich food and vitamin D), doing the recommended amount of exercise including weight-bearing activities, rest and relaxation, knowing the risks associated with the menopause and HRT, routine examinations (e.g. breast) and screening, and being aware when medical advice should be sought (e.g. for vaginal bleeding, breast changes, suspected blood clot, severe headache)
- You can also signpost to websites such as NHS (www.nhs.uk/conditions/menopause/), Rock My Menopause (www.rockmymenopause.com), Menopause Matters (www.menopausematters.co.uk), Women's Health Concern (www.womens-health-concern.org), the Royal College of Obstetricians and Gynaecologists (www.rcog.org.uk), The Daisy Network (www.daisynetwork.org) is for women who have premature ovarian insufficiency or premature menopause
- Reclassified POM→P: 2022