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

NCT06651541 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BZ371CLI602
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Sexual Arousal Disorder; Female Sexual Dysfunction (FSD)

Keywords

sexual dysfunction; Topical application; female

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks and 8 weeks

Secondary Outcomes (11)

• Efficacy in increasing desire, lubrification, orgasm and arousal

  Baseline, 4 weeks and 8 weeks

• Evaluation of the quality of female sexual encounters

  Baseline, 4 weeks and 8 weeks

• Female Sexual Function Index (FSFI)

  Baseline, 4 weeks and 8 weeks

• Assessment of treatment satisfaction

  Baseline, 4 weeks and 8 weeks

• Adverse effects report

  Baseline, 4 weeks, 8 weeks and 10 weeks after baseline

Study Arms (4)

BZ371A group (0.5 ml)

EXPERIMENTAL

The medication will be administered at least twice a week (according to demand), followed by sexual encounters, for 8 weeks

Drug: BZ371A (0.5 ml); Drug: Placebo (0.5 ml)

Placebo Group (0.5 ml)

PLACEBO COMPARATOR

The medication will be administered at least twice a week (according to demand), followed by sexual encounters, for 8 weeks

Drug: BZ371A (0.5 ml); Drug: Placebo (0.5 ml)

Placebo Group (1.0 ml)

PLACEBO COMPARATOR

The medication will be administered at least twice a week (according to demand), followed by sexual encounters, for 8 weeks

Drug: Placebo (1.0 ml); Drug: BZ371A (1.0 ml)

BZ371A group (1.0 ml)

EXPERIMENTAL

The medication will be administered at least twice a week (according to demand), followed by sexual encounters, for 8 weeks

Drug: Placebo (1.0 ml); Drug: BZ371A (1.0 ml)

Interventions

BZ371A (0.5 ml) DRUG

Formulation with the active ingredient

BZ371A group (0.5 ml); Placebo Group (0.5 ml)

Placebo (0.5 ml) DRUG

Formulation without the active ingredient

BZ371A group (0.5 ml); Placebo Group (0.5 ml)

Placebo (1.0 ml) DRUG

Formulation without the active ingredient

BZ371A group (1.0 ml); Placebo Group (1.0 ml)

BZ371A (1.0 ml) DRUG

Formulation with the active ingredient

BZ371A group (1.0 ml); Placebo Group (1.0 ml)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: heterosexual
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Presence of genital lesions that impair analysis of local adverse effects on the genitalia;
• Presence of diseases that cause excessive vaginal discharge, such as recurrent urinary tract infection, vaginal infection and pelvic inflammatory disease.
• Abnormal Papanicolaou test within the past 3 years;
• History of gynecological cancer (history of uterine dysplasia can be included, provided it has been properly treated for at least 6 months);
• History of pelvic irradiation;

Sponsors & Collaborators

• Biozeus Biopharmaceutical S.A.: lead

Study Sites (1)

Ambulatório Jenny Farias do Hospital das Clínicas da UFMG

Belo Horizonte, Brazil

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Fabiene Vale, MD PhD

  Hospital das Clínicas - UFMG

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)