Use of transdermal Testosterone in women with decreased sexual desire and tendency for aggressiveness: a double blind randomized clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Administration, Topical Drug Drug Evaluation Experimental group: 35 women with hypoactive sexual desire will receive transdermal biolipid‐associated testosterone nanoemulsion (1 gram puff containing 300mcg / day). Control group: 35 women with hypoactive sexual desire will receive transdermal biolipid‐associated placebo (1 gram puff containing 300mcg / day). The test and control groups were randomly determined. The formulations should be applied to the inner region of the forearm or thigh after bathing for a period of 12 weeks. CONDITION: F00‐F99 Lack or loss of sexual desire Lack or loss of sexual desire ; Lack or loss of sexual desire PRIMARY OUTCOME: Evaluate behavioral changes with a tendency towards aggressiveness after the intervention, determined by a change of classification in a validated questionnaire (aggressiveness tendency assessment scale) applied at the beginning and end of the study SECONDARY OUTCOME: To determine improvement in sexual desire after intervention, assessed by increasing of the total score of a validated questionnaire (female sexual function index) applied at the beginning and end of the study INCLUSION CRITERIA: Women between 18 and 45 years old with regular menstrual cycles; decreased sexual desire; sexual activity present with at least one sexual event per month with actual partner; be in good general health; use of an effective contraceptive method; women over 40 years old should have a clinically acceptable mammogram in the last 2 years;
Epistemonikos ID: 0f0e3c09c637dc04bd4384664cf9ea157a840129
First added on: Aug 24, 2024