PLEASE NOTE: MEDICINE IS NO LONGER AUTHORIZED
What is Livensa?
Livensa is a transdermal patch (a patch that delivers the medicine through the skin). The patch releases 300 micrograms of the active testosterone over 24 hours.
What is Livensa used for?
Livensa is used in the treatment of patients whose uterus or both ovaries have been removed, in case of suffering caused by the absence of libido and sexual desire. It is indicated in patients who are already using estrogen (a female sex hormone). The medicine can only be obtained with a prescription.
How is Livensa used?
Livensa is used as a continuous 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 or four days and is subsequently replaced by a new patch, placed in a different application site. Avoid reapplication in the same place for at least seven days. It may take more than a month for the patient to feel the benefits. If patients experience no benefit after three to six months of treatment, they should contact their doctor to change therapy.
How does Livensa work?
The active ingredient in Livensa, testosterone, is a natural sex hormone produced in humans and, to a lesser extent, in women. Low testosterone levels have been linked to lower sexual desire and reduced libido and excitement. In women who have had their uterus and ovaries removed, the amount of testosterone produced is halved. Livensa releases testosterone into the bloodstream through the skin to produce hormone levels equal to those prior to removal of the uterus and ovaries.
What studies have been carried out on Livensa?
Testosterone is a well-known and already used active ingredient in other medicines; for this reason the company, in addition to performing its own studies, has 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 a year. Livensa was compared with a placebo (a patch that did not contain any active ingredients). In the studies, a questionnaire created specifically to measure interest and sexual activity was used, by recording the number of satisfactory sexual episodes over a four-week period. The main measure of the effectiveness of the medicine was given by the variations in the scores attributed before the start of the study and after six months of treatment.
What benefits has Livensa shown during the studies?
Livensa was more effective than placebo. Analyzing the whole of the results of the two studies it is observed that the patients treated with Livensa reported an average improvement of 1.07 more satisfactory sexual episodes compared to the patients treated with placebo over four weeks. This means that, on average, the number of satisfactory sexual episodes in the reference period of four weeks has increased from three before treatment to about five episodes in the same time frame after taking Livensa for six months. Instead, women who had been given placebo for six months reported about four episodes over a four-week period.
What are the risks associated with Livensa?
The most common side effects of Livensa (seen in more than 1 patient in 10) are hirsutism (increased hairs especially on the chin and upper lip) and reactions in the area of application of the patch (redness and itching). For the complete list of side effects reported with Livensa, see the package leaflet. Testosterone is a male sex hormone; therefore, it is advisable to monitor patients who use Livensa in case of adverse effects related to the androgenic effects of testosterone (development of masculine characteristics such as growth of facial hair, deeper voice or hair loss). If these effects are observed, please consult your doctor.
Livensa should not be used in people who are hypersensitive (allergic) to testosterone or any of the other substances. It must not be used by women who have been, or who have been, affected by breast cancer or other forms of malignant tumor induced by estrogen or other diseases that prevent them from taking medicines containing estrogen.
Patients who use Livensa must also take estrogen, 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 the benefits of Livensa outweigh the risks in the treatment of hypoactive sexual desire disorder in patients undergoing bilateral oophorectomy and hysterectomy receiving concomitant estrogen therapy. The CHMP therefore recommended that it be given marketing authorization for this medicine.
What measures are being taken to ensure the safe use of Livensa?
The company that makes Livensa will carefully monitor some of the adverse effects of the product, such as androgenic side effects. The company will carry out a review of ongoing Livensa studies to look at potential long-term risks, including breast cancer, endometrial cancer (the lining of the uterine cavity) and side effects on the heart and blood vessels. The manufacturing company will also provide a plan of instructions to doctors and patients.
More information about Livensa:
On 28 July 2006, the European Commission granted Livter a marketing authorization valid throughout the European Union to Procter & Gamble Pharmaceuticals - Germany GmbH.
For the full version of the evaluation (EPAR) of Livensa, click here.
Last update of this summary: 05-2008.
