Evaluation of the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder
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;
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;
Parallel
BZ371A (0.5 ml)
DrugFormulation with the active ingredient
Placebo (0.5 ml)
DrugFormulation without the active ingredient
Placebo (1.0 ml)
DrugFormulation without the active ingredient
BZ371A (1.0 ml)
DrugFormulation with the active ingredient
Efficacy in increasing arousal
Evaluation of the efficacy of BZ371A in increasing arousal using Female Sexual Encounter Profile (FSEP) questionnaire. The study will evaluate number of "yes" answers to question 3 in the Female Sexual Encounter Profile (FSEP) questionnaire, divided by the number of valid attempts (question 7 of the FSEP). The study will evaluate the increase in the FSEP score based on the baseline FSEP value, obtained before using the BZ371A. Thus, the higher the number of yes answers, the better the efficacy of the drug.
Efficacy in increasing desire, lubrification, orgasm and arousal
Evaluation of the success rate for desire, lubrification, orgasm and for arousal using Female Sexual Encounter Profile (FSEP). The number of successes for desire will be assessed using FSEP Question 2 / FSEP Question 7, for lubrication FSEP Question 4 / FSEP Question 7, for orgasm FSEP Question 5 / FSEP Question 7 and for the degree of arousal FSEP Question 6 / FSEP Question 7. For each question, the number of "yes" answers will be counted as success. Therefore, for each "no" answer the value will be 0 and for each "yes" answer the value will be 1.
Evaluation of the quality of female sexual encounters
Evaluation based on the total score of the Female Sexual Encounter Profile (FSEP) questionnaire. The score ranges from 0 to 9. Therefore, the higher the score, the better the participant's sexual encounter.
Female Sexual Function Index (FSFI)
Evaluation of the score for each domain (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) using the Female Sexual Function Index (FSFI) questionnaire. The score ranges from 2 to 36. Thus, the higher the score, the better the participant's sexual satisfaction.
Assessment of treatment satisfaction
Response rate to the Global Assessment Question (GAQ), by the number of "yes" answers to the question about arousal and sexual pleasure.
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