What is Intrinsa?
What is Intrinsa used for?
How is Intrinsa used?
How does Intrinsa work?
How has Intrinsa been studied?
What benefit has Intrinsa shown during the studies?
What is the risk associated with Intrinsa?
Why has Intrinsa been approved?
Which measures are being taken to ensure the safe use of Intrinsa?
Other information about Intrinsa.
Intrinsa package leaflet
Summary of product characteristics
What is Intrinsa?Intrinsa is a transdermal patch (administers the drug through the skin). The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Intrinsa is used to treat women who have had their uterus (womb) and both ovaries removed, when they have a lack of sexual thoughts and sexual desire that causes them distress. It is used in patients already taking an estrogen (a female sex hormone). The medicine can only be obtained with a
prescription.
How is Intrinsa used?Intrinsa is a continuous treatment that requires a new patch twice a week. The patch is applied to dry, clean skin on the lower abdomen ( below the waist). The patch remains on the skin for 3 or 4 days and is then replaced by a new one in a different place. The same place must not be used again until at least 7 days later. It may take longer than a month for the patient to see an improvement. A patient who, after 3 to 6 months of treatment, is not benefiting should contact her doctor and have her treatment reviewed.
How does Intrinsa work?The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and to a lesser extent in women. Low testosterone levels have been associated with low sexual desire and reduced sexual thoughts and arousal. In women who have had their uterus and ovaries removed, the amount of testosterone produced is halved. Intrinsa releases testosterone through the skin into the bloodstream to obtain testosterone levels that match the levels before surgery.
How has Intrinsa been studied?Because testosterone is a well known active substance already used in other medicines, the company used data from the published literature as well as carrying out studies itself. The main studies of the effectiveness of Intrinsa involved 1,095 women (average age: 49) who received Intrinsa for up to a year. Intrinsa was compared with a placebo (a dummy treatment). The studies used a specially designed questionnaire to measure sexual interest and activity (number of satisfying sexual episodes in a 4-week period), and the measure of effectiveness was based on the change in the questionnaire score before the study (baseline) and after 6 months (24 weeks) of treatment with the medicine.
What benefit has Intrinsa shown during the studies?Intrinsa was more effective than placebo: when the results of all studies were analysed together, an average improvement of 1.07 satisfying sexual episodes over a 4-week period was seen in women who received Intrinsa in comparison to the women who received a placebo. This means that, on average, women who, before treatment, had on average a baseline of 3 satisfying sexual episodes in a 4-week period, had 5 such episodes in a 4-week period after having taken Intrinsa for 6 months. Women who took a placebo for 6 months had on average 4 episodes in a 4-week period at the end of the study.
What is the risk associated with Intrinsa?The most common side effects (seen in more than 1 patient in 10) were reactions at the site of application of the patch (redness, itching). For the full list of all side effects reported with Intrinsa, see the Package Leaflet. Because testosterone is a male sex hormone, women who are taking Intrinsa should be monitored to see if they develop any adverse effects linked to the androgenic effects of testosterone (development of male characteristics, such as hair growth on the face, deepening of the voice, hair loss). Women should contact their doctor if they notice any of these effects. Intrinsa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients. It should also not be used in women who have, or have had breast cancer or other estrogen-dependent cancer, or who have other conditions that stop them from being able to take estrogen-containing medicines. Women using Intrinsa should also use estrogens, but not of the type known as ‘conjugated estrogens’ as this combination is not as effective.
Why has Intrinsa been approved?The Committee for Medicinal Products for Human Use (CHMP) concluded that Intrinsa had shown that it was more effective than placebo in relieving the symptoms of hypoactive sexual desire disorder in women who have had their uterus and both ovaries removed. They decided that Intrinsa’s benefits are greater than its risks and recommended that Intrinsa be given marketing authorisation.
Which measures are being taken to ensure the safe use of Intrinsa?The company that makes Intrinsa will monitor closely some of the side effects of Intrinsa, such as the androgenic side effects. It will review all ongoing studies with Intrinsa to look at potential long-term risks (breast cancer, endometrial cancer, cardiovascular side effects). It will provide an educational plan for both doctors and patients.
Other information about Intrinsa.The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa to Procter & Gamble Pharmaceuticals UK Ltd on 28 July 2006.
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Intrinsa package leaflet
