A Phase 2 interventional study of BZ371A 7.5 mg (1.5 ml) and BZ371A 5.0 mg (1.0 ml) in Female Sexual Arousal Disorder and Female Sexual Dysfunction, sponsored by Biozeus Biopharmaceutical S.A.. Recruiting at 1 site in Brazil. Open to female participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Biozeus Biopharmaceutical S.A. · Phase 2, Interventional, and Treatment
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
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.
138 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 114 interventional studies indexed under Sexual Dysfunctions, Psychological.
Browse Sexual Dysfunctions, Psychological studies →Biozeus Biopharmaceutical S.A. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: BZ371A 7.5 mg (1.5 ml) · Drug: Placebo (1.5 ml)
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.
Drug: BZ371A 7.5 mg (1.5 ml) · Drug: Placebo (1.5 ml)
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.
Drug: BZ371A 5.0 mg (1.0 ml) · Drug: Placebo (1.0 ml)
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.
Drug: BZ371A 5.0 mg (1.0 ml) · Drug: Placebo (1.0 ml)
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.
Drug: BZ371A 2.5 mg (0.5 ml) · Drug: Placebo (0.5 ml)
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.
Drug: BZ371A 2.5 mg (0.5 ml) · Drug: Placebo (0.5 ml)
Drug pages: BZ-371A · NOS Enhancer BZ371A
7.5 mg gel
Also known as: BZ371A
Drug pages: BZ-371A · NOS Enhancer BZ371A
5.0 mg gel
Also known as: BZ371A
Drug pages: BZ-371A · NOS Enhancer BZ371A
2.5 mg gel
Also known as: BZ371A
BZ371A-matched placebo
Also known as: Placebo
BZ371A-matched placebo
Also known as: Placebo
BZ371A-matched placebo
Also known as: Placebo
Efficacy in increasing arousal
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.
Time frame: Baseline, 4 weeks and 8 weeks
Efficacy in increasing desire, lubrification, orgasm and arousal
Evaluation of the success rate for desire, lubrification, orgasm and for arousal using Female Sexual Encounter Profile (FSEP). The number of successes for desire will be assessed using FSEP Question 2 / FSEP Question 7, for lubrication FSEP Question 4 / FSEP Question 7, for orgasm FSEP Question 5 / FSEP Question 7 and for the degree of arousal FSEP Question 6 / FSEP Question 7. For each question, the number of "yes" answers will be counted as success. Therefore, for each "no" answer the value will be 0 and for each "yes" answer the value will be 1.
Time frame: Baseline, 4 weeks and 8 weeks
Evaluation of the quality of female sexual encounters
Evaluation based on the total score of the Female Sexual Encounter Profile (FSEP) questionnaire. The score ranges from 0 to 9. Therefore, the higher the score, the better the participant's sexual encounter.
Time frame: Baseline, 4 weeks and 8 weeks
Efficacy in increasing genital blood flow
Evaluation of the efficacy of BZ371A in increasing genital blood flow using Cytocam system
Time frame: 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)
Evaluation of the score for each domain (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) using the Female Sexual Function Index (FSFI) questionnaire. The score ranges from 2 to 36. Thus, the higher the score, the better the participant's sexual satisfaction.
Time frame: Baseline, 4 weeks and 8 weeks
Assessment of treatment satisfaction
Response rate to the Global Assessment Question (GAQ), by the number of "yes" answers to the question about arousal and sexual pleasure.
Time frame: 4 weeks after baseline and 8 weeks after baseline
Adverse effects report
Adverse effects evaluation of compound use and application
Time frame: 4 weeks after baseline, 8 weeks after baseline and, approximately, 11 weeks after baseline
Physical examination of the genitalia
Number of participants with abnormal physical exam findings in the applied region.
Time frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in systemic blood pressure
Change in Diastolic Blood Pressure and Systolic Blood Pressure
Time frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in Heart Rate (HR)
Change in Heart Rate
Time frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Basal chest electrocardiogram (ECG)
Number of participants with abnormal electrocardiogram (ECG) findings.
Time frame: From up to 30 days before Baseline, 4 weeks after baseline, 8 weeks after baseline
Blood evaluation
Number of participants with abnormal laboratory test results
Time frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Urine evaluation
Number of participants with abnormal laboratory test results
Time frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
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Studies of the drugs tested here: BZ-371A · NOS Enhancer BZ371A
Sexual Dysfunctions, Psychological →
Biozeus Biopharmaceutical S.A.