Study of S1B-408 in Women With Orgasmic Dysfunction

NCT06516055 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: S1B-408-2000
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orgasmic Disorder

Keywords

S1B-408; Orgasmic Disorder; Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in Sexual Function Questionnaire (CSFQ): orgasm

  7 day recall

• CSFQ total score

  "now" or 7 day recall

• FSFI total score

  Prior 7 or 28 days

• Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) items 13, 14, and 15 scores

  Prior 7 or 28 days

• Sexual Activity Log (SAL), orgasms

  1-7 day recall

Other Outcomes (7)

• Safety: adverse events

  4-week recall

• pulse rate

  one fourth to one half minute

• Blood pressure

  one half minute or less

Study Arms (1)

S1B-408

EXPERIMENTAL

One dose of S1B-408 with up-titration of one of its components after one week as needed and tolerated

Drug: S1B-408

Interventions

S1B-408 DRUG

Medication with multiple monoamine activities

S1B-408

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25 to 60.
• In a sexual relationship and sexually active within the past month
• Diagnosis of ICD-10 2023 Orgasmic Dysfunction, secondary or primary. See Investigator's Brochure, section 2, "Medical Need and Diagnosis" for rationale.
• Orgasmic Dysfunction is the predominant form of sexual dysfunction, is acquired rather than lifelong, and is generalized rather than situational.
• At screen and baseline visit, scores \<8 on the raw score of the FSFI orgasm domain (at least moderate severity)
• 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
• Side effects from any continuing concomitant medications must be stable.
• 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.
• Gives informed consent for and is willing to undergo all of the scheduled evaluations
• Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations
• 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).
• Agrees to have sexual activity with her partner at least once a week for the duration of her participation in this study.

You may not qualify if:

• Masturbates to orgasm more than once a week.
• Sexual aversion or sexual pain disorder
• 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.
• Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs
• History of bipolar and/or psychotic disorders and/or takes an antiepileptic/mood stabilizer, antipsychotic, or opioid drug
• History of severe, serious, or allergic adverse reaction(s) to stimulants or sedatives
• Drinks \>2 alcoholic drinks per day (12-oz beer, 4-oz wine, 1 ½ oz liquor, etc.)
• History of seizures or use of antiepileptic medication
• Long QT syndrome (QTc \>480 msec), other significant cardiovascular disease
• moderate or severe dysfunction of the liver (any LFT \>3x ULN) or renal dysfunction (BUN \> 30 or Cr \>2.0)
• 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.

Sponsors & Collaborators

• S1 Biopharma, Inc.: lead

Related Publications (1)

• 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.

  PMID: 31678098 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nicolas E Sitchon, B.S.

  S1 Biopharma, Inc.

  STUDY CHAIR

Central Study Contacts

Anita Clayton, MD

CONTACT

4342434649; AHC8V@hscmail.mcc.virginia

Robert E Pyke, MD,PhD

CONTACT

2033992390; robertepyke@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Rating scales and sexual activity log to establish baseline over one month then open-label treatment with dose titration based on results to determine change, with statistical analysis of group differences between month prior to treatment vs treatment.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share