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Tests treatment safety and results for Female Sexual Arousal Disorder
Official title Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder
ClinicalTrials.gov ID: NCT06116045
What this study is testing
What is BZ371A 7.5 mg (1.5 ml)?
BZ371A 7.5 mg (1.5 ml) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for female sexual arousal disorder.
Also referred to as BZ371A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60, women only
You may be able to join 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...
- Women with FSAD who present marked suffering or interpersonal difficulties;
You likely can't join 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;
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rio de Janeiro, Rio de Janeiro, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rio de Janeiro, Rio de Janeiro, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.