Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516055
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Study of S1B-408 in Women With Orgasmic Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIa Non-Blinded Study of Safety Tolerability and Efficacy of S1B-408 in Women With Orgasmic Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is the first clinical trial of S1B-408 in women with sexual dysfunction A prior 4-week trial in premenopausal women with Hypoactive Sexual Desire Disorder showed that orgasmic function improved with Lorexys TM This pilot trial tests for improvement in orgasmic function safety and tolerability of a different but related test article
Detailed Description:
S1B-408 is a proprietary combination of agents proven safe and effective in other CNS indications The combination drug is aimed at treating womens sexual dysfunction disorders Its two components each have pro-sexual effects However the efficacy of each when given alone has been limited Moreover each component has side effects which while benign may limit the drugs utility activation agitation anxiety insomnia with one sedation somnolence fatigue etc with the other
The goal of this trial is to show that when formulated in the proper fixed ratio the combination of these two drugs strengthens their pro-sexual effects for orgasmic dysfunction while mitigating the opposing side effect profiles
For this pilot study the goal for exposure is to seek rapid onset of action with minimal dosing
The goal of this trial is to show that when formulated in the proper fixed ratio the combination of these two drugs strengthens their pro-sexual effects for orgasmic dysfunction while mitigating the opposing side effect profiles
For this pilot study the goal for exposure is to seek rapid onset of action with minimal dosing
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