Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Wom… (NCT06651541) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder
Brazil174 participantsStarted 2026-07-01
Plain-language summary
Evaluation of the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder
Who can participate
Age range21 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged between 21 and 65 years;
* Premenopausal or postmenopausal women may be included;
* May or may not be using female sex hormones (estrogen with or without progesterone, or their derivatives);
* Women who have previously had sexual experiences with orgasm, desire, and arousal, for a minimum period of two years;
* FSD, defined according to DSM-IV diagnostic criteria, that is, the presence of a persistent or recurrent inability to achieve or maintain adequate physiological sexual arousal during sexual activity, meaning a reduction or absence of genital response (lubrication, clitoral swelling, or other genital responses such as genital pleasure sensations);
* FSD causes significant personal distress and/or interpersonal difficulty;
* FSFI questionnaire meeting criteria for female sexual dysfunction, i.e., \<26.5;
* Stable relationship for more than 6 months, with a sexually active partner who is present (cannot be traveling, for example) during the treatment period;
* Ability to read and understand the Informed Consent Form (ICF) and to complete the questionnaires.
Exclusion Criteria:
* Women who do not agree to use a contraceptive method and who have the capacity to become pregnant during the study;
* Women who do not agree to attempt sexual activity at least twice a week while taking the study medication;
* Serious relationship problems, defined as a CSI-16 score below 51.5, of non-sexual origin, and which, in the investigator's opinion, may …