A methodological investigation to test acute changes in female sexual desire in healthy volunteersand pre- and postmenopausal women diagnosed with hypoactive sexual desiredisordersusing 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. - PDS study
- Conditions
- hypoactive sexual desire disorder in women (HSDD)MedDRA version: 9.1Level: LLTClassification code 10062641Term: Female sexual arousal disorder
- Registration Number
- EUCTR2007-003343-74-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 132
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 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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