Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651541
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Evaluation of the Efficacy in Increasing Sexual Arousal Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Parallel 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the efficacy in increasing sexual arousal safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder
Detailed Description:
Female 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None