NCT06516055

Study of S1B-408 in Women With Orgasmic Dysfunction

A Phase IIa Non-Blinded Study of Safety, Tolerability and Efficacy of S1B-408 in Women With Orgasmic Dysfunction

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: S1 Biopharma, Inc. · Industry
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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 women's 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 drug's 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.

Conditions

• Orgasmic Disorder

Interventions

Type	Name	Description
DRUG	S1B-408	Medication with multiple monoamine activities

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2024-07-23
• Last updated: 2025-04-27

Regulatory

• FDA-regulated drug study