PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Livensa?
Livensa is a transdermal patch (a patch that delivers medicine through the skin). The patch releases 300 micrograms of the active ingredient testosterone per 24 hours.
What is Livensa used for?
Livensa is used in the treatment of patients who have had their uterus or both ovaries removed, in case of suffering caused by the absence of libido and sexual desire. It is indicated in patients who already use estrogen (female sex hormone). The medicine can only be obtained with a prescription.
How is Livensa used?
Livensa is used as an ongoing treatment, applying a patch twice a week. The patch should be applied to clean, dry skin at the lower abdomen. The patch remains in contact with the skin for three to four days and is subsequently replaced by a new patch placed at a different application site. Avoid reapplication in the same spot for at least seven days. It may take more than a month for the patient to feel any benefit. therapy.
How does Livensa work?
The active substance in Livensa, testosterone, is a natural sex hormone produced in men and to a lesser extent in women. Low testosterone levels have been linked to lower sex drive and reduced libido and arousal. In women they have been. once the uterus and ovaries are removed, the amount of testosterone produced is halved.Livensa releases testosterone into the blood through the skin, so as to produce hormone levels equal to those prior to the removal of the uterus and ovaries.
What studies have been carried out on Livensa?
Testosterone is a well known active ingredient already used in other medicines; for this reason the manufacturing company, in addition to carrying out its own studies, used data from the published literature. The two main studies on the effectiveness of Livensa involved 1,095 women, with an average age of 49, who took the medicine for up to one year. Livensa was compared with a placebo (a patch that did not contain any active substances). The studies used a questionnaire created specifically to measure sexual interest and activity, by recording the number of satisfactory sexual episodes over a four-week period. The main measure of the drug's effectiveness was given by changes in the scores assigned. before the start of the study and after six months of treatment.
What benefit has Livensa shown during the studies?
Livensa was more effective than placebo. Analyzing the results of the two studies together, it is observed that patients treated with Livensa reported an average improvement of 1.07 more satisfactory sexual episodes compared to patients treated with placebo over a four-week period. This means that, on average, the number of satisfactory sexual episodes over the four-week reference period went from three before treatment to about five episodes over the same timeframe after taking Livensa for six months. Women given placebo for six months reported about four episodes over four weeks.
What are the risks associated with Livensa?
The most common side effects with Livensa (seen in more than 1 in 10 patients) are hirsutism (increased hair especially on the chin and upper lip) and reactions in the patch application area (redness and itching). For the full list of side effects reported with Livensa, see the package leaflet. Testosterone is a male sex hormone; therefore, it is advisable to monitor patients using Livensa in case of adverse effects related to the androgenic effects of testosterone (development of male characteristics such as growth of facial hair, deeper voice or hair loss). In case such effects are observed, please consult your doctor.
Livensa must not be used in people who are hypersensitive (allergic) to testosterone or any of the other substances. It must not be used by women with, or who have been, breast cancer or other forms of estrogen-induced malignancy or other conditions that prevent them from taking medicines containing estrogen.
Patients using Livensa must also take estrogens, as long as they are different from the so-called "conjugated estrogens", as this combination is less effective.
Why has Livensa been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Livensa's benefits are greater than its risks in the treatment of hypoactive sexual desire disorder in patients undergoing bilateral oophorectomy and hysterectomy receiving concomitant estrogen therapy. The CHMP therefore recommended the granting of a marketing authorization for this medicine.
What measures are being taken to ensure the safe use of Livensa?
The company that makes Livensa will closely monitor some of the adverse effects of the product, such as androgenic side effects. The company will review Livensa's ongoing studies to look at potential long-term risks, including breast cancer, cancer of the endometrium (the lining of the uterine cavity) and side effects on the heart and blood vessels. The manufacturing company will also provide an instruction plan for doctors and patients.
Other information about Livensa:
On July 28, 2006, the European Commission granted Procter & Gamble Pharmaceuticals - Germany GmbH a "Marketing Authorization" for Livensa, valid throughout the European Union.
For the full version of the Livensa evaluation (EPAR), click here.
Last update of this summary: 05-2008.
The information on Livensa - testosterone published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
