A methodological investigation to test acute changes in female sexual desire in healthy volunteers and pre- and postmenopausal women diagnosed with hypoactive sexual desire disorders using explicit measures in a controlled laboratory setting and behavioral measures at home, in no-drug as well as placebo-controlled within subjects cross-over drug (a single dose of testosterone gel 50mg [1% in 5g] conditions.

Sexual desire problems in women appear to be common, with prevalence rates
between 30 and 35%. Sexual desire has been seen as a general and rather
enduring quality, rather than a state that fluctuates. Yet in women there is
evidence of some sexual desire fluctuation throughout the menstrual cycle and
in response to environmental changes. In addition, desire is correlated with
sexual arousal changes as measures in the psychophysiology lab and in
questionnaires. It thus seems important to develop and evaluate methodologies
aimed at detecting acute changes in sexual desire.

In order to better understand sexual desire (e.g., fluctuations in desire,
level of desire to distinct sexual stimuli varying in intensity, subtypes of
desire disorder) it is important to examine methods for rapid detection of
desire changes. Furthermore, it is important to find out if one or a
combination of methods might later be valuable for detecting change caused by
pharmacological or psychological treatment interventions

The main study consists of two parts. In the first part, pre- and
postmenopausal women with Hypoactive Sexual Desire Disorder (HSDD) will be
compared to sexually functional women (SF) on the different measures during two
experimental sessions. A 3 (group) x 8 (measure) x 2 (measure order) design
will be employed with group and measure order as between-subject variables and
measure as within-subject variable. The measures consist of questionnaires,
implicit tasks, psychophysiological measures and a behavioral measure (home
assessment of sexual desire/activities (diary)). Assignment of measure order
will be counterbalanced among participants.
In the second part, a randomised, cross-over double blind and placebo
controlled study will be conducted among pre- and postmenopausal HSDD women.
The effect of a single dose testosterone 50 milligram on sexual desire and
arousal will be compared with placebo using the same measures as in the first
study part. A 2 (group) x 2 (medication) x 2 (medication order) x 8 (measure) x
(measure order) design will be employed with group, medication order and
measure order as between-subject variables and medication and measure as
within-subject variables. Assignment of medication order (testosterone *
placebo or placebo * testosterone) will be counterbalanced among participants.
Again, assignment of measure order will be counterbalanced among participants.
Prior to the main study, a pilot-study will be conducted to test the full
protocol in two pre- and two postmenopausal HSDD women and two SF women. The
main purpose is to assess subject burden and procedural imperfections.

In the second part, a randomised, cross-over double blind and placebo
controlled study will be conducted among pre- and postmenopausal HSDD women.
The effect of a single dose testosterone 50 milligram on sexual desire and
arousal will be compared with placebo using the same measures as in the first
study part.

Participants may find some study parts unpleasant, such as watching erotic
visual materials, answering questions regarding sexuality, the tapping of
blood, or the placement of the vaginal instrument for the vaginal
photoplethysmography. The vaginal instrument will be disinfected prior to each
use. The facial electrodes for the assessment of ASR are safe, although they
may cause temporal skin irritation. This irritation will disappear by itself.
There are some possible side-effects of the study medication, such as skin
irritation, (redness, burning sensation), extra fluid in the body, acne,
hirsutism, fatty skin, hair loss, lower voice, headache, higher blood levels,
liver abnormalities, changes in cholesterol, transpiration. The likelihood of
these side-effects to occur is supposed to be very small, since the medication
will be applied only once. We consider the burden to be moderate and the risk
low.