Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21-60
SponsorBiozeus Biopharmaceutical S.A.
About this trial
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
Eligibility criteria
Qualifiers
Women between the ages 21 and 60;
Pre-menopausal or post-menopausal women may be included;
May or may not be taking female sex hormones (estrogen with or without progesterone, or their derivatives);
FSAD, defined as the inability, persistent or recurrent, to obtain or maintain until the conclusion of sexual activity an adequate genital response to sexual arousal (lubrication, warmth and enlargement of the clitoris);
Disqualifiers
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;
History of unresolved sexual trauma or abuse;
Diagnosis of vaginismus, genitopelvic pain/penetration disorder and/or sexual aversion disorder;
Trial design
Treatments tested in this trial
- BZ371A 7.5 mg (1.5 ml)
- BZ371A 5.0 mg (1.0 ml)
- BZ371A 2.5 mg (0.5 ml)
- Placebo (1.5 ml)
- Placebo (1.0 ml)
- Placebo (0.5 ml)
Treatment groups
30 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov