Intrarosa
Authorised
This medicine is authorised for use in the European Union
prasterone
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Intrarosa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Intrarosa.
For practical information about using Intrarosa, patients should read the package leaflet or contact their doctor or pharmacist.
Intrarosa is a medicine used to treat postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy. In women with vulvar and vaginal atrophy, the wall of the vagina and surrounding tissues become thinner and can cause symptoms such as dryness, irritation and soreness around the genital area, and painful sexual intercourse.
Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA).
Intrarosa is available as a 6.5 mg pessary. Women should insert the pessary into their vagina, once daily, at bedtime.
The medicine can only be obtained with a prescription. For further information, see the package leaflet.
In women who have been through the menopause, the thinning of the tissues in and around the vagina is caused by a fall in levels of the sex hormone oestrogen.
The active substance of Intrarosa, prasterone, is converted into the sex hormones oestrogens and androgens when inserted into the vagina. As a result of increasing oestrogen levels, the number of superficial cells in the tissues in and around the vagina increases thus relieving the symptoms of vaginal atrophy.
Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues.
In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks. Results showed that the number of superficial cells (which normally falls with atrophy) increased by 6% and 10% with Intrarosa compared with about 1% and 2% with placebo. There was also a decrease in the number of parabasal cells (which normally increase with atrophy) of 42% and 47% with Intrarosa compared with 2% and 12% with placebo.
In addition, Intrarosa treatment was better at increasing acidity in the vagina (which normally becomes less acidic with atrophy), with pH values reducing by 0.9 and 1.0 with Intrarosa and by 0.2 and 0.3 with placebo.
Patients taking Intrarosa had a modest reduction in pain during sexual intercourse, which was similar or better to the effect seen in patients taking placebo. Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain). The pain reduced by 1.3 and 1.4 points with Intrarosa compared with 0.9 and 1.1 points with placebo. The effect seen in the placebo group was explained by the lubricant effect of the excipient.
The most common side effect with Intrarosa (which may affect up to 1 in 10 people) is vaginal discharge. For the full list of side effects reported with Intrarosa, see the package leaflet.
Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (short-term) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins). For the full list of restrictions, see the package leaflet.
Intrarosa has been shown to improve the structure of the vaginal tissues and to have a modest effect on pain during sexual intercourse. The medicine has an acceptable safety profile.
The European Medicines Agency therefore considered that Intrarosa’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intrarosa have also been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Intrarosa on 8 January 2018.
For more information about treatment with Intrarosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: S/0044
07/12/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Intrarosa
- Active substance
- Prasterone
- International non-proprietary name (INN) or common name
- prasterone
- Therapeutic area (MeSH)
- Postmenopause
- Anatomical therapeutic chemical (ATC) code
- G03XX01
Pharmacotherapeutic group
Other sex hormones and modulators of the genital systemTherapeutic indication
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
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