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

NCT06116045 | Recruiting Phase 2 DMC

• 1 other identifier: BZ371CLI601
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine 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

Keywords

Female; Sexual arousal disorder; Sexual dysfunction; FSFI questionnaire; Nitric Oxide; Topic

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 (12)

• 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

• Efficacy in increasing genital blood flow

  Baseline, 4 weeks (pre-dose, 15, 30, 60, 90 and 120 minutes) and 8 weeks (pre-dose, 15, 30, 60, 90 and120 minutes)

• Female Sexual Function Index (FSFI)

  Baseline, 4 weeks and 8 weeks

• Assessment of treatment satisfaction

  4 weeks after baseline and 8 weeks after baseline

Study Arms (6)

Group A - BZ371A, then Placebo

EXPERIMENTAL

Participants will first receive topical BZ371A 7.5 mg for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical Placebo to be used daily for 2 weeks.

Drug: BZ371A 7.5 mg (1.5 ml); Drug: Placebo (1.5 ml)

Group B - Placebo, then BZ371A

EXPERIMENTAL

Participants will first receive topical Placebo for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical BZ371A 7.5 mg to be used daily for 2 weeks.

Drug: BZ371A 7.5 mg (1.5 ml); Drug: Placebo (1.5 ml)

Group C - BZ371A, then Placebo

EXPERIMENTAL

Participants will first receive topical BZ371A 5.0 mg for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical Placebo to be used daily for 2 weeks.

Drug: BZ371A 5.0 mg (1.0 ml); Drug: Placebo (1.0 ml)

Gorup D - Placebo, then BZ371A

EXPERIMENTAL

Participants will first receive topical Placebo for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical BZ371A 5.0 mg to be used daily for 2 weeks.

Drug: BZ371A 5.0 mg (1.0 ml); Drug: Placebo (1.0 ml)

Group E - BZ371A, then Placebo

EXPERIMENTAL

Participants will first receive topical BZ371A 2.5 mg for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical Placebo to be used daily for 2 weeks.

Drug: BZ371A 2.5 mg (0.5 ml); Drug: Placebo (0.5 ml)

Group F - Placebo, then BZ371A

EXPERIMENTAL

Participants will first receive topical Placebo for daily use for 2 weeks. After a washout period of 2 weeks, they will receive topical BZ371A 2.5 mg to be used daily for 2 weeks.

Drug: BZ371A 2.5 mg (0.5 ml); Drug: Placebo (0.5 ml)

Interventions

BZ371A 7.5 mg (1.5 ml) DRUG

7.5 mg gel

Also known as: BZ371A

Group A - BZ371A, then Placebo; Group B - Placebo, then BZ371A

BZ371A 5.0 mg (1.0 ml) DRUG

5.0 mg gel

Also known as: BZ371A

Gorup D - Placebo, then BZ371A; Group C - BZ371A, then Placebo

BZ371A 2.5 mg (0.5 ml) DRUG

2.5 mg gel

Also known as: BZ371A

Group E - BZ371A, then Placebo; Group F - Placebo, then BZ371A

Placebo (1.5 ml) DRUG

BZ371A-matched placebo

Also known as: Placebo

Group A - BZ371A, then Placebo; Group B - Placebo, then BZ371A

Placebo (1.0 ml) DRUG

BZ371A-matched placebo

Also known as: Placebo

Gorup D - Placebo, then BZ371A; Group C - BZ371A, then Placebo

Placebo (0.5 ml) DRUG

BZ371A-matched placebo

Also known as: Placebo

Group E - BZ371A, then Placebo; Group F - Placebo, then BZ371A

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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;
• 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;
• 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)

Centro de Pesquisa Clínica Multiusuário (CePeM)

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases; Urogenital Diseases

Study Officials

• Marco Aurélio Oliveira, MD

  Centro de Pesquisa Clínica Multiusuário (CePeM)

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

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

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 3, 2023
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 31, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

BR (1)