Loading clinical trials...

Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

Phase 2 Parallel Clinical Study to Evaluate the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Gel Form Applied to Women With Sexual Arousal Disorder

NCT06651541•Biozeus Biopharmaceutical S.A.

View on ClinicalTrials.gov

Summary

Evaluation of the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder

Detailed Description

Female Sexual Arousal Disorder (FSAD) is defined as the recurrent inability to attain or maintain sufficient genital arousal during sexual activity. Therefore, a healthy blood flow is central to the physiological processes related to sexual arousal, leading to genital lubrication, warmth, and clitoral protrusion. The vasculature and blood flow in vaginal tissue can be compromised due to natural aging and various risk factors, including cigarette smoking, alcohol abuse, lack of exercise, high-fat diets, hypertension, hypercholesterolemia, and diabetes mellitus. All these risk factors and conditions are highly prevalent among women and can lead to FSAD. BZ371A offers a potential solution by increasing blood flow in genital tissue through its unique mechanism of action, thereby restoring vascular homeostasis and the physiological processes related to sexual arousal in women.

Eligibility

Age

21 - 65 years

Sex

FEMALE

Healthy Volunteers

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 influence sexual activities;
•History of unresolved sexual trauma or abuse, that could interfere with participation or the results of the study;
•Diagnosis of vaginismus, genitopelvic pain/penetration disorder and/or sexual aversion disorder;
•Uncontrolled diabetes at screening visit (HbA1C \> 10%);
•Prior spinal cord injury, with lower limb paralysis;
•History of abdominal or pelvic surgery that may have damaged pelvic nerves, including vulvectomy, colostomy, cytostomy, hysterectomy, or bladder suspension;
•Current testosterone use, or long-term testosterone use (such as chip) within the past 6 months;
•Patients with severe current depression, characterized by the use or need for the use of psychotropic medications, including bupropion, lithium, or neuroleptics (patients using antidepressant medications such as selective serotonin reuptake inhibitors may participate);
+24 more criteria

Locations (1)

Ambulatório Jenny Farias do Hospital das Clínicas da UFMG

Belo Horizonte, Brazil

Key Dates

Start Date

July 1, 2026

Primary Completion Date

June 30, 2027

Completion Date

July 31, 2027

Last Updated

November 17, 2025

Enrollment

174

ESTIMATED participants

Conditions

Female Sexual Arousal DisorderFemale Sexual Dysfunction (FSD)

Interventions

BZ371A (0.5 ml)

DRUG

Placebo (0.5 ml)

DRUG

Placebo (1.0 ml)

DRUG

BZ371A (1.0 ml)

DRUG

Contacts

Camilla N R Trindade, PhD

CONTACT

+55 21 25239089 camilla.nunes@biozeus.com.br

Gabriela W Neves, PhD

CONTACT

+55 21 25239089 gabriela.westerlund@biozeus.com.br

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

NCT06116045

Female Sexual Arousal DisorderFemale Sexual Dysfunction

View study

UNKNOWNNA

Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

NCT03820453

Female Sexual Arousal Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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

Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder