Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorBiozeus Biopharmaceutical S.A.

About this trial

Evaluation of 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 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;

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;

Serious relationship problems, defined as a CSI-16 score below 51.5, of non-sexual origin, and which, in the investigator's opinion, may influence sexual activities;

History of unresolved sexual trauma or abuse, that could interfere with participation or the results of the study;

Trial design

Treatments tested in this trial

  • BZ371A (0.5 ml)
  • Placebo (0.5 ml)
  • Placebo (1.0 ml)
  • BZ371A (1.0 ml)

Treatment groups

174 Participants
are divided into 4 treatment groups

Sponsors and collaborators