Evaluating a new gel for 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

This study is testing a new gel to see if it can help women with sexual arousal disorder feel more aroused and improve their sexual experiences.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years to 60 Years
• Sex: Female
• Sponsor: Biozeus Biopharmaceutical S.A. (Industry-sponsored)
• Locations: 1 site (Rio de Janeiro, Rio de Janeiro)
• Trial ID: NCT06116045 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy, safety, and tolerability of BZ371A, a gel formulation, in women diagnosed with Female Sexual Arousal Disorder (FSAD). The study will involve administering different dosages of BZ371A to participants, who will be monitored for improvements in sexual arousal and related physiological responses. The trial focuses on understanding how BZ371A can enhance blood flow to genital tissues, which is crucial for sexual arousal. Participants will be required to engage in sexual activity at least twice a week during the study period to evaluate the gel's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are pre-menopausal or post-menopausal women aged 21 to 60 who experience recurrent difficulties in achieving genital arousal during sexual activity.

Not a fit: Patients with a history of unresolved sexual trauma or abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve sexual arousal and overall sexual satisfaction for women suffering from FSAD.

How similar studies have performed: While there have been studies on treatments for sexual dysfunction, the specific approach of using BZ371A in this manner is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Rio de Janeiro, Rio de Janeiro

• Centro de Pesquisa Clínica Multiusuário (CePeM) — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)

Study contacts

• Principal investigator: Marco Aurélio Oliveira, MD — Centro de Pesquisa Clínica Multiusuário (CePeM)
• Study coordinator: Camilla Trindade, PhD

Conditions Female Sexual Arousal Disorder; Female Sexual Dysfunction; Female; Sexual arousal disorder; Sexual dysfunction; FSFI questionnaire; Nitric Oxide; Topic