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.

Conditions: Sexual desire problems in women
10040480

Registration Number: NL-OMON30937

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

Inclusion criteria for all women are: being in a stable relationship; being in general good health; having a hetero- or bisexual orientation; aged between 18-45 (premenopausal) and 50-65 (postmenopausal), using a reliable form of contraception. Inclusion criteria for HSDD women are: minimally 6 months complaints of HSDD; HSDD participants may also be experiencing arousal and orgasm problems (except for sexual pain problems), but the HSDD must be the primary problem. Inclusion-criterion for SF women is: no sexual complaints during the past 6 months.

Exclusion Criteria

Exclusion criteria for all women are: medications that would interfere with sexual functioning; illness or disease interfering with sexual functioning (including diabetes, cancer in the past 5 years); active depression, pregnancy or the intent to become pregnant; sexual problems in the woman*s partner, that make sexual activity impossible; postmenopausal women on hormone replacement therapy; vaginal procedures that might interfere with vaginal vascularisation and/or innervation of vaginal tissue.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Level of sexual desire as assessed with questionnaires and tasks during which<br /><br>participants have to judge sexual stimuli. Reaction times and number of errors<br /><br>as assessed with implicit tasks. Genital arousal responses (VPA) as assessed<br /><br>with vaginal photoplethysmograpy and subjective ratings of sexual arousal as<br /><br>assessed with questions while being exposed to sexual stimuli. Acoustic Startle<br /><br>Reflex (ASR) as measure for approach to/avoidance of sexual stimuli.<br /><br>Additionally, the effects of testosterone gel on abovementioned variables will<br /><br>be measured in women with HSDD</p><br>

Secondary Outcome Measures