Female Sexual Arousal DisorderPhase 2NCT06116045
Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder
A Phase 2 study testing BZ371A 7.5 mg (1.5 ml), BZ371A 5.0 mg (1.0 ml) and BZ371A 2.5 mg (0.5 ml) in people with Female Sexual Arousal Disorder and Female Sexual Dysfunction, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
Trial summary
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Female Sexual Arousal Disorder, Female Sexual Dysfunction
- What is being tested?
- BZ371A 7.5 mg (1.5 ml), BZ371A 5.0 mg (1.0 ml) and BZ371A 2.5 mg (0.5 ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2024to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Pesquisa Clínica Multiusuário (CePeM)
Rio de Janeiro, Rio de Janeiro, 20551030
Ana Kamilla da Cruz Silva, 55 21 28688000, estudofeminino2024@gmail.com
About this study
Official title: 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
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
Read the detailed description
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.
- Being tested
- BZ371A 7.5 mg (1.5 ml), BZ371A 5.0 mg (1.0 ml), BZ371A 2.5 mg (0.5 ml), Placebo (1.5 ml), Placebo (1.0 ml)
- Keywords
- Female, Sexual arousal disorder, Sexual dysfunction, FSFI questionnaire, Nitric Oxide, Topic
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BZ371A 7.5 mg (1.5 ml)Drug
Also called BZ371A
7.5 mg gel
BZ371A 5.0 mg (1.0 ml)Drug
Also called BZ371A
5.0 mg gel
BZ371A 2.5 mg (0.5 ml)Drug
Also called BZ371A
2.5 mg gel
Placebo (1.5 ml)Drug
Also called Placebo
BZ371A-matched placebo
Placebo (1.0 ml)Drug
Also called Placebo
BZ371A-matched placebo
Placebo (0.5 ml)Drug
Also called Placebo
BZ371A-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A - BZ371A, then Placebo | Experimental | 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. Receives: Drug: BZ371A 7.5 mg (1.5 ml); Drug: Placebo (1.5 ml) |
| Group B - Placebo, then BZ371A | Experimental | 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. Receives: Drug: BZ371A 7.5 mg (1.5 ml); Drug: Placebo (1.5 ml) |
| Group C - BZ371A, then Placebo | Experimental | 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. Receives: Drug: BZ371A 5.0 mg (1.0 ml); Drug: Placebo (1.0 ml) |
| Gorup D - Placebo, then BZ371A | Experimental | 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. Receives: Drug: BZ371A 5.0 mg (1.0 ml); Drug: Placebo (1.0 ml) |
| Group E - BZ371A, then Placebo | Experimental | 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. Receives: Drug: BZ371A 2.5 mg (0.5 ml); Drug: Placebo (0.5 ml) |
| Group F - Placebo, then BZ371A | Experimental | 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. Receives: Drug: BZ371A 2.5 mg (0.5 ml); Drug: Placebo (0.5 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 weeks after baseline and 8 weeks after baseline
Adverse effects report
Adverse effects evaluation of compound use and application
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Arousal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biozeus Biopharmaceutical S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Aurélio Oliveira, MD, Principal investigator, Centro de Pesquisa Clínica Multiusuário (CePeM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116045
- Sponsor's protocol ID
- BZ371CLI601
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06116045
- Acronym / sponsor ID
- BZ371CLI601
- Keywords
- Female, Sexual arousal disorder, Sexual dysfunction, FSFI questionnaire, Nitric Oxide, Topic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Biozeus Biopharmaceutical S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A - BZ371A, then Placebo | Experimental | Drug: BZ371A 7.5 mg (1.5 ml), Drug: Placebo (1.5 ml)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. |
| Group B - Placebo, then BZ371A | Experimental | 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. |
| Group C - BZ371A, then Placebo | Experimental | Drug: BZ371A 5.0 mg (1.0 ml), Drug: Placebo (1.0 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. |
| Gorup D - Placebo, then BZ371A | Experimental | 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. |
| Group E - BZ371A, then Placebo | Experimental | Drug: BZ371A 2.5 mg (0.5 ml), Drug: Placebo (0.5 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. |
| Group F - Placebo, then BZ371A | Experimental | 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (29 listed)
- 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%);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BZ371A 7.5 mg (1.5 ml)Also: BZ371A7.5 mg gel | Drug | Group A - BZ371A, then Placebo, Group B - Placebo, then BZ371A |
| BZ371A 5.0 mg (1.0 ml)Also: BZ371A5.0 mg gel | Drug | Gorup D - Placebo, then BZ371A, Group C - BZ371A, then Placebo |
| BZ371A 2.5 mg (0.5 ml)Also: BZ371A2.5 mg gel | Drug | Group E - BZ371A, then Placebo, Group F - Placebo, then BZ371A |
| Placebo (1.5 ml)Also: PlaceboBZ371A-matched placebo | Drug | Group A - BZ371A, then Placebo, Group B - Placebo, then BZ371A |
| Placebo (1.0 ml)Also: PlaceboBZ371A-matched placebo | Drug | Gorup D - Placebo, then BZ371A, Group C - BZ371A, then Placebo |
| Placebo (0.5 ml)Also: PlaceboBZ371A-matched placebo | Drug | Group E - BZ371A, then Placebo, Group F - Placebo, then BZ371A |
Primary outcome
Efficacy in increasing arousal
Time frame: 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.
12 secondary outcomes
Efficacy in increasing desire, lubrification, orgasm and arousal
Time frame: Baseline, 4 weeks and 8 weeks
Evaluation of the quality of female sexual encounters
Time frame: Baseline, 4 weeks and 8 weeks
Efficacy in increasing genital blood flow
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)
Time frame: Baseline, 4 weeks and 8 weeks
Assessment of treatment satisfaction
Time frame: 4 weeks after baseline and 8 weeks after baseline
Adverse effects report
Time frame: 4 weeks after baseline, 8 weeks after baseline and, approximately, 11 weeks after baseline
Physical examination of the genitalia
Time frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Change in systemic 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)
Time frame: From up to 30 days before Baseline, Baseline, 4 weeks, 8 weeks and, approximately, 11 weeks
Basal chest electrocardiogram (ECG)
Time frame: From up to 30 days before Baseline, 4 weeks after baseline, 8 weeks after baseline
Blood evaluation
Time frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Urine evaluation
Time frame: From up to 30 days before Baseline, 4 weeks after baseline and 8 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Aurélio Oliveira, MD principal investigator
Centro de Pesquisa Clínica Multiusuário (CePeM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BZ371A 7.5 mg (1.5 ml), BZ371A 5.0 mg (1.0 ml) and BZ371A 2.5 mg (0.5 ml) in people with Female Sexual Arousal Disorder and Female Sexual Dysfunction, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Trindade, PhD (+55 21 25239089, camilla.nunes@biozeus.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in increasing arousal (time frame: Baseline, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.