Extrait

Background and study aims Hypoactive Sexual Desire Disorder is a problem affecting many women. These women have extremely low or no sexual desire and they are very distressed by this. If your low sexual desire is caused by a bad relationship with your partner, a high amount of stress, another illness that you have, or it is a side effect of medication that you are taking, you do not have Hypoactive Sexual Desire Disorder. There are several medications being tested to see if they help solve these problems in sexual desire. One of these medications has two active ingredients: testosterone and sildenafil. Testosterone and sildenafil have to be taken in two different ways because otherwise, the medication doesn’t work. The testosterone is dissolved under the tongue and the sildenafil tablet is swallowed. In earlier studies, these two ingredients were administered separately (the old way). Now a tablet has been made that combines these two ingredients into one tablet (the new way). This study investigates if these two different ways of taking the medication, the old way and the new way, are the same. This is done by comparing the blood levels of testosterone and sildenafil in women who take the medication in the old way and in the new way. Who can participate? Healthy women between the ages of 18 and 35. What does the study involve? The women are first screened by a physician to see if they are eligible to participate in the study. If so, they are invited to the research centre for two overnight visits. During the first overnight visit they are given the medication in the old or new form. Just before taking the medication blood is drawn. After taking the medication, blood is drawn another 27 times over a period of 26 and a half hours. During the second overnight visit, the women are given the other medication form and blood is drawn in the same way as the first visit. The subjects blood is sent to a laboratory where it is tested for how much of each drug is in the blood at different points in time. What are the possible benefits and risks of participating? The participants are given 828 Euros for participation and a fixed fee of 38 Euros for travel expenses. A total amount of 246.2 ml of blood is drawn from each participant during the entire study. Participants may experience side effects from the medication. The most common side effects are headache, flushing, nausea, a runny nose and dizziness. Where is the study run from? University Medical Center Groningen ( Netherlands). When is the study starting and how long is it expected to run for? December 2010 to July 2011. Who is funding the study? Emotional Brain B.V. (Netherlands).

Critère d'inclusion

• Hypoactive Sexual Desire Disorder

Liens

• isrctn
• ictrp