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

RECRUITINGPHASE2

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

Phase 2 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

NCT06116045•Biozeus Biopharmaceutical S.A.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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 - 60 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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);
•Women with FSAD who present marked suffering or interpersonal difficulties;
•Stable relationship for more than 6 months, with a sexually active partner;
•Ability to read and understand the Informed Consent Form (ICF) and to answer 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;
•History of unresolved sexual trauma or abuse;
•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;
•Presence of menstrual irregularity or endocrinopathies that significantly alter the menstrual cycle, preventing Cytocam analyses from taking place at the same time;
•Patients with current depression, characterized by the use or need for use of psychotropic drugs, including bupropion, lithium, or neuroleptics;
+19 more criteria

Locations (1)

Centro de Pesquisa Clínica Multiusuário (CePeM)

Rio de Janeiro, Rio de Janeiro, Brazil

Key Dates

Start Date

October 1, 2024

Primary Completion Date

February 1, 2025

Completion Date

March 31, 2025

Last Updated

October 22, 2024

Enrollment

ESTIMATED participants

Conditions

Female Sexual Arousal DisorderFemale Sexual Dysfunction

Interventions

BZ371A 7.5 mg (1.5 ml)

DRUG

BZ371A 5.0 mg (1.0 ml)

DRUG

BZ371A 2.5 mg (0.5 ml)

DRUG

Placebo (1.5 ml)

DRUG

Placebo (1.0 ml)

DRUG

Placebo (0.5 ml)

DRUG

Contacts

Camilla Trindade, PhD

CONTACT

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

Gabriela Westerlund, PhD

CONTACT

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

Sexual Effects of Transdermal or Vaginal Testosterone

NCT06794346

Female Sexual DysfunctionPostmenopausal Symptoms+2 more

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NOT_YET_RECRUITINGPHASE2

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

NCT06651541

Female Sexual Arousal DisorderFemale Sexual Dysfunction (FSD)

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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: October 22, 2024Data 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.

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

Inclusion Criteria

Exclusion Criteria

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