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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy in increasing arousal
研究概览
简要总结
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: BZ371A 7.5 mg (1.5 ml) (Drug)
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.
干预措施: Placebo (1.5 ml) (Drug)
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.
干预措施: BZ371A 7.5 mg (1.5 ml) (Drug)
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.
干预措施: Placebo (1.5 ml) (Drug)
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.
干预措施: BZ371A 5.0 mg (1.0 ml) (Drug)
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.
干预措施: Placebo (1.0 ml) (Drug)
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.
干预措施: BZ371A 5.0 mg (1.0 ml) (Drug)
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.
干预措施: Placebo (1.0 ml) (Drug)
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.
干预措施: BZ371A 2.5 mg (0.5 ml) (Drug)
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.
干预措施: Placebo (0.5 ml) (Drug)
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.
干预措施: BZ371A 2.5 mg (0.5 ml) (Drug)
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.
干预措施: Placebo (0.5 ml) (Drug)
结局指标
主要结局
Efficacy in increasing arousal
时间窗: 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.
次要结局
- Urine evaluation(From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline)
- Efficacy in increasing desire, lubrification, orgasm and arousal(Baseline, 4 weeks and 8 weeks)
- Evaluation of the quality of female sexual encounters(Baseline, 4 weeks and 8 weeks)
- Efficacy in increasing genital blood flow(Baseline, 4 weeks (pre-dose, 15, 30, 60, 90 and 120 minutes) and 8 weeks (pre-dose, 15, 30, 60, 90 and120 minutes))
- Female Sexual Function Index (FSFI)(Baseline, 4 weeks and 8 weeks)
- Assessment of treatment satisfaction(4 weeks after baseline and 8 weeks after baseline)
- Adverse effects report(4 weeks after baseline, 8 weeks after baseline and, approximately, 11 weeks after baseline)
- Physical examination of the genitalia(From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks)
- Change in systemic blood pressure(From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks)
- Change in Heart Rate (HR)(From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks)
- Basal chest electrocardiogram (ECG)(From up to 30 days before Baseline, 4 weeks after baseline, 8 weeks after baseline)
- Blood evaluation(From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline)