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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Female Sexual Arousal Disorder, Female Sexual Dysfunction

In brief

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

Key facts

Study ID

NCT06116045

Run by

Biozeus Biopharmaceutical S.A.

People needed

30

Starts

2024-10-01

Expected to finish

2025-03-31

Last updated by the study team

2024-10-22

Who can join

Age: 21 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

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;
• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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