hypoactive sexual desire disorder in women (HSDD) MedDRA version: 9.1 Level: LLT Classification code 10062641 Term: Female sexual arousal disorder
Conditions
Interventions
Trade Name: Androgel (in Dutch Testogel)
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for all women are: being in a stable relationship; being in general good health; having a hetero- or bisexual orientation; using a reliable form of contraception. Inclusion criteria for HSDD women are: aged between 18-45 (premenopausal) and 50-65 (postmenopausal), 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: aged between 18-45 (premenopausal); no sexual complaints during the past 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives 1. Test which measures or combination of measures, selected for their likelihood of tapping the domain of sexual desire broadly, best detect acute changes in sexual desire in women who have no sexual dysfunction vs. those reporting HSDD. 2. Test sensitivity and precision of these measures for detecting desire changes in response to a selected agent with past evidence of causing acute changes in sexual desire/arousal. 3. Test the Acute Female Sexual Desire Scale for its ability to summarize sexual arousal changes occurring in the laboratory setting and outside. ;Secondary Objective: Secondary objectives 1. Begin to develop subtypes of sexual desire problems in women, particularly ‘general’ and ‘partner specific’. 2. Examine differences between pre and postmenopausal women regarding the usefulness of each measure or combination of measures to detect desire changes. 3. Examine differences, consistencies between lab experience and following 24 hours in terms of sexual desire and behaviour. 4. Predict those women who are desire ‘responders’ in the lab, using demographic, hormonal status (per lab values) and selected sexuality variables. 5. Study test-retest reliability by calculating correlations between the first and second visit and third and fourth visit for the primary objectives ;Primary end point(s): Level of sexual desire as assessed with questionnaires and tasks during which participants have to judge sexual stimuli. Reaction times and number of errors as assessed with implicit tasks. Genital arousal responses (VPA) as assessed with vaginal photoplethysmograpy and subjective ratings of sexual arousal as assessed with questions while being exposed to sexual stimuli. Acoustic Startle Reflex (ASR) as measure for approach to/avoidance of sexual stimuli. Additionally, the effects of testosterone gel on abovementioned variables will be measured in women with HSDD. | — |
Countries
Netherlands
Outcome results
None listed