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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orgasmic Disorder
• Intervention / Treatment: Drug: S1B-408

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anita Clayton, MD; Phone Number: 4342434649; Email: AHC8V@hscmail.mcc.virginia
• Study Contact Backup: Name: Robert E Pyke, MD,PhD; Phone Number: 2033992390; Email: robertepyke@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 25 to 60.
2. In a sexual relationship and sexually active within the past month
3. Diagnosis of ICD-10 2023 Orgasmic Dysfunction, secondary or primary. See Investigator's Brochure, section 2, "Medical Need and Diagnosis" for rationale.
4. Orgasmic Dysfunction is the predominant form of sexual dysfunction, is acquired rather than lifelong, and is generalized rather than situational.
5. At screen and baseline visit, scores <8 on the raw score of the FSFI orgasm domain (at least moderate severity)
6. May have depression and/or anxiety if condition is no worse than mild with treatment and if patient will continue the same treatment for the duration of this trial
7. Side effects from any continuing concomitant medications must be stable.
8. Not pregnant or lactating for six months; using contraception that is medically reliable in the investigator's judgment, or (if the investigator finds the patient credibly monogamous) vasectomy of male partner. If hormonal contraception is used, the same medication must have been used for at least 3 months.
9. Gives informed consent for and is willing to undergo all of the scheduled evaluations
10. Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations
11. Her sexual partner is sexually unimpaired (erectile dysfunction allowed only if adequately treated), and available to the subject at least half of the time (in days per week).
12. Agrees to have sexual activity with her partner at least once a week for the duration of her participation in this study.

Exclusion Criteria:

1. Masturbates to orgasm more than once a week.
2. Sexual aversion or sexual pain disorder
3. Chronic conditions that, in the investigator's judgment, are likely to deteriorate within 3 months of screening are not allowed (e.g., gastrointestinal bleeding, uncontrolled diabetes, frequent asthma attacks, uncontrolled Major Depressive disorder, history within the prior 6 months of suicidality or drug abuse; recurrence within the prior year of breast, cervical, uterine, ovarian or other systemic cancer). However, chronic conditions with a relatively stable course are allowed; see Investigator's Brochure, section 2, "Medical Need and Diagnosis" for rationale.
4. Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs
5. History of bipolar and/or psychotic disorders and/or takes an antiepileptic/mood stabilizer, antipsychotic, or opioid drug
6. History of severe, serious, or allergic adverse reaction(s) to stimulants or sedatives
7. Drinks >2 alcoholic drinks per day (12-oz beer, 4-oz wine, 1 ½ oz liquor, etc.)
8. History of seizures or use of antiepileptic medication
9. Long QT syndrome (QTc >480 msec), other significant cardiovascular disease
10. moderate or severe dysfunction of the liver (any LFT >3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0)
11. History of blood clots or abnormal bleeding tendencies, including daily use of medications adversely affecting coagulation, e.g., NSAIDs, systemic corticosteroids, or >81 mg aspirin daily.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S1B-408; One dose of S1B-408 with up-titration of one of its components after one week as needed and tolerated	Drug: S1B-408; Medication with multiple monoamine activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index (FSFI): orgasm domain	sum of 3 items on orgasmic frequency, difficulty, and satisfaction, each rated 0 or 1 (worst) to 5 (best)	7 or 28 day recall

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Sexual Function Questionnaire (CSFQ): orgasm	sum of 3 items on orgasmic frequency, pleasure, and ability, each rated 1 (worst) to 5 (best)	7 day recall
CSFQ total score	sum of 14 items on all aspects of female sexual response, scored from 14 to 70 (best)	"now" or 7 day recall
FSFI total score	sum of 19 items on 6 aspects of female sexual response, scored from 4 (worst) to 95 (best)	Prior 7 or 28 days
Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) items 13, 14, and 15 scores	3 items on sexual distress re desire, arousal, and orgasm, each scored from 0 to 4 (best)	Prior 7 or 28 days
Sexual Activity Log (SAL), orgasms	Sexual Activity Log count of orgasms	1-7 day recall
SAL proportion of sexual activities with orgasm	Sexual Activity Log count of orgasms over times engaged in sex; best would be 1.0	1-7 day recall
Sexual Activity Log (SAL) satisfying sexual events	Count of sexual events that were satisfying	1-7 day recall
Patient's Global Impression of Change	single question rated from 1 (best) to 7 (worst) asking improvement vs none or worsening	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: adverse events	All adverse outcomes in clinician's judgment in answer to a question: How do you feel? or in interpreting objective information about the patient	4-week recall
pulse rate	number of heart beats per minute effective enough to reach the arm	one fourth to one half minute
Blood pressure	pressures in mm of mercury when a heartbeat reaches the arm and between heartbeats	one half minute or less
Q-T interval	time in milliseconds between start and end of a contraction of the ventricles of the heart as measured by electrocardiogram (ECG)	three heartbeats up to the number of heartbeats in 30 seconds
Cardiac rate	Number of contractions of the ventricles of the heart per minute as measured by ECG	1/2 to 1 minute
Columbia Suicide Severity Rating Scale, 6-item Screening/Triage version (C-SSRS-6)	6-item self-rating scale on suicidal ideas, intent and behavior monitored by clinician; "no" rather than "yes" answer to each item is best score	prior 30 days
Patient Health Questionnaire-9 Symptom Checklist (PHQ-9)	9 items on depressive symptoms rated from 0 (best) to 3 (worst)	prior 2 weeks

Collaborators and Investigators

• Sponsor: S1 Biopharma, Inc.
• Investigators: Study Chair: Nicolas E Sitchon, B.S., S1 Biopharma, Inc.

Publications and helpful links

General Publications

• Pyke RE, Clayton AH. Dose-Finding Study of Lorexys for Hypoactive Sexual Desire Disorder in Premenopausal Women. J Sex Med. 2019 Dec;16(12):1885-1894. doi: 10.1016/j.jsxm.2019.09.005. Epub 2019 Oct 31.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Female Sexual Dysfunction; Orgasmic Disorder; S1B-408
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: S1B-408-2000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No