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

October 18, 2024 updated by: Biozeus Biopharmaceutical S.A.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20551030
        • Recruiting
        • Centro de Pesquisa Clínica Multiusuário (CePeM)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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;
  • 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;
  • Use of topical medications in the genital region that may interfere with PSI assessment as well as their absorption or drug interaction, including vaginal estrogens, lubricants, spermicides, creams or gels, vaginal douches;
  • History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart disease (including history of angina and/or heart failure) and nephropathies;
  • Current use of nitrates, such as propatylnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and sosorbitol dinitrate (Isocord®)
  • ECG findings that are clinically symptomatic, or that, in the Investigator's judgment, are considered significant and pose a risk to the research volunteer's participation;
  • Findings on laboratory tests that, in the Investigator's judgment, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;
  • TSH outside normal limits for age (participants with hypothyroidism on stable dose of medication, over 3 months, may be included);
  • BP outside safe limits: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except for situations such as "white coat" syndrome
  • Severe hypertension, considered as use of three or more antihypertensives;
  • Diseases that can cause clitoral priapism, such as sickle cell anemia, multiple myeloma or leukemia;
  • History of clitoral priapism;
  • Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or malabsorptive syndrome, or presence of mucus, pus, or blood in the stool;
  • Pregnant or lactating;
  • Current use of nitric oxide donors, guanylate cyclase stimulators (e.g. Riociguat), or 5- phosphodiesterase inhibitors (Sildenafil, Tadalafil, etc.);
  • Any disease or condition or physical finding that the Investigator considers significant and that increases the risk of the research participant's participation or may interfere with the results, including serious debilitating diseases, presence of cancer, serious mental illness, persistent abuse of medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A - BZ371A, then Placebo
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)
7.5 mg gel
Other Names:
  • BZ371A
Drug: Placebo (1.5 ml)
BZ371A-matched placebo
Other Names:
  • Placebo
Experimental: Group B - Placebo, then BZ371A
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)
7.5 mg gel
Other Names:
  • BZ371A
Drug: Placebo (1.5 ml)
BZ371A-matched placebo
Other Names:
  • Placebo
Experimental: Group C - BZ371A, then Placebo
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)
5.0 mg gel
Other Names:
  • BZ371A
Drug: Placebo (1.0 ml)
BZ371A-matched placebo
Other Names:
  • Placebo
Experimental: Gorup D - Placebo, then BZ371A
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)
5.0 mg gel
Other Names:
  • BZ371A
Drug: Placebo (1.0 ml)
BZ371A-matched placebo
Other Names:
  • Placebo
Experimental: Group E - BZ371A, then Placebo
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)
2.5 mg gel
Other Names:
  • BZ371A
Drug: Placebo (0.5 ml)
BZ371A-matched placebo
Other Names:
  • Placebo
Experimental: Group F - Placebo, then BZ371A
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)
2.5 mg gel
Other Names:
  • BZ371A
Drug: Placebo (0.5 ml)
BZ371A-matched placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy in increasing arousal
Time Frame: Baseline, 4 weeks and 8 weeks

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy in increasing desire, lubrification, orgasm and arousal
Time Frame: Baseline, 4 weeks and 8 weeks

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.
Baseline, 4 weeks and 8 weeks
Evaluation of the quality of female sexual encounters
Time Frame: Baseline, 4 weeks and 8 weeks
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.
Baseline, 4 weeks and 8 weeks
Female Sexual Function Index (FSFI)
Time Frame: Baseline, 4 weeks and 8 weeks
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.
Baseline, 4 weeks and 8 weeks
Assessment of treatment satisfaction
Time Frame: 4 weeks after baseline and 8 weeks after baseline
Response rate to the Global Assessment Question (GAQ), by the number of "yes" answers to the question about arousal and sexual pleasure.
4 weeks after baseline and 8 weeks after baseline
Adverse effects report
Time Frame: 4 weeks after baseline, 8 weeks after baseline and, approximately, 11 weeks after baseline
Adverse effects evaluation of compound use and application
4 weeks after baseline, 8 weeks after baseline and, approximately, 11 weeks after baseline
Physical examination of the genitalia
Time Frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Number of participants with abnormal physical exam findings in the applied region.
From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in systemic blood pressure
Time Frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in Diastolic Blood Pressure and Systolic Blood Pressure
From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in Heart Rate (HR)
Time Frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in Heart Rate
From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Blood evaluation
Time Frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Number of participants with abnormal laboratory test results
From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Urine evaluation
Time Frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Number of participants with abnormal laboratory test results
From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Efficacy in increasing genital blood flow
Time Frame: Baseline, 4 weeks (pre-dose, 15, 30, 60, 90 and 120 minutes) and 8 weeks (pre-dose, 15, 30, 60, 90 and120 minutes)
Evaluation of the efficacy of BZ371A in increasing genital blood flow using Cytocam system
Baseline, 4 weeks (pre-dose, 15, 30, 60, 90 and 120 minutes) and 8 weeks (pre-dose, 15, 30, 60, 90 and120 minutes)
Basal chest electrocardiogram (ECG)
Time Frame: From up to 30 days before Baseline, 4 weeks after baseline, 8 weeks after baseline
Number of participants with abnormal electrocardiogram (ECG) findings.
From up to 30 days before Baseline, 4 weeks after baseline, 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biozeus Biopharmaceutical S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco Aurélio Oliveira, MD, Centro de Pesquisa Clínica Multiusuário (CePeM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BZ371CLI601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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