Actively Recruiting
Phase 2 Clinical Study to Evaluate the Efficacy, Safety and Tolerability of BZ371A Gel in Women with Sexual Arousal Disorder
Led by Biozeus Biopharmaceutical S.A. · Updated on 2024-10-22
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of BZ371A gel on women suffering from Female Sexual Arousal Disorder (FSAD), a condition marked by the ongoing inability to maintain genital arousal during sexual activity. The study aims to assess the gel's ability to increase sexual arousal, its safety, and how well it is tolerated. FSAD can arise from reduced blood flow in vaginal tissues, influenced by factors such as aging, smoking, diet, and certain health conditions. The study is a randomized, quadruple-blind trial comparing different doses of BZ371A gel (7.5 mg, 5.0 mg, and 2.5 mg) with a placebo. Participants will use the gel daily for two weeks, followed by a two-week washout period, and then switch to the alternate treatment for another two weeks. This crossover design allows each participant to receive both BZ371A and placebo in different sequences. Participants will attend visits at baseline, 4 weeks, 8 weeks, and approximately 11 weeks for various assessments. These include measuring sexual arousal, desire, lubrication, orgasm, genital blood flow, and satisfaction with treatment. Safety monitoring involves physical exams, blood pressure, heart rate, ECGs, and laboratory tests. The study measures changes from baseline at several time points to evaluate both efficacy and safety over the treatment period.
CONDITIONS
Brief Title
Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Diagnosis of Female Sexual Arousal Disorder characterized by persistent or recurrent inability to maintain adequate genital arousal
- Women with FSAD experiencing significant distress or relationship difficulties
- Stable relationship for more than 6 months with a sexually active partner
- Ability to read and understand the informed consent form and complete questionnaires
You will not qualify if you...
- Women not agreeing to use contraception and who can become pregnant during the study
- Women unwilling to attempt sexual activity at least twice a week during the study
- History of unresolved sexual trauma or abuse
- Diagnosis of vaginismus, genitopelvic pain/penetration disorder, or sexual aversion disorder
- Uncontrolled diabetes at screening (HbA1C > 10%)
- Prior spinal cord injury causing lower limb paralysis
- History of abdominal or pelvic surgery that may damage pelvic nerves
- Current or recent long-term testosterone use within 6 months
- Menstrual irregularity or endocrinopathies interfering with assessments
- Current depression requiring psychotropic medications
- Genital lesions impairing local adverse effect analysis
- Diseases causing excessive vaginal discharge
- Abnormal Pap test within past 3 years
- History of gynecological cancer or pelvic irradiation
- Use of topical genital medications interfering with assessments
- History of symptomatic hypotension or related heart/kidney diseases
- Current use of nitrates or certain heart medications
- Abnormal ECG or lab findings posing risk to participation
- Thyroid hormone levels outside normal range unless stable hypothyroidism
- Blood pressure outside safe limits
- Severe hypertension requiring multiple medications
- Diseases causing clitoral priapism or history of clitoral priapism
- Current relevant diarrhea lasting over four weeks
- Pregnant or lactating women
- Use of nitric oxide donors, guanylate cyclase stimulators, or PDE5 inhibitors
- Any condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks total (two 2-week treatment periods with a 2-week washout)
Participants receive topical BZ371A gel or placebo daily in a crossover design with two 2-week treatment periods separated by a 2-week washout period.
Visits at baseline, 4 weeks, and 8 weeks for assessments
Duration - Approximately 3 weeks after treatment completion
Participants are monitored for safety and treatment satisfaction approximately 3 weeks after baseline.
1 visit approximately 11 weeks after baseline
Trial Site Locations
Total: 1 location
1
Centro de Pesquisa Clínica Multiusuário (CePeM)
Rio de Janeiro, Rio de Janeiro, Brazil, 20551030
Actively Recruiting
Research Team
C
Camilla Trindade, PhD
G
Gabriela Westerlund, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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