Clinical trial NCT06516055: Study of S1B-408 in Women With Orgasmic Dysfunction
Official title: A Phase IIa Non-Blinded Study of Safety, Tolerability and Efficacy of S1B-408 in Women With Orgasmic Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Orgasmic Disorder
Keywords: S1B-408
Orgasmic Disorder
Female Sexual Dysfunction
Lead sponsor: S1 Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Female Sexual Function Index (FSFI): orgasm domain
timeFrame: 7 or 28 day recall
Secondary outcomes:
measure: Changes in Sexual Function Questionnaire (CSFQ): orgasm
timeFrame: 7 day recall
measure: CSFQ total score
timeFrame: "now" or 7 day recall
measure: FSFI total score
timeFrame: Prior 7 or 28 days
measure: Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) items 13, 14, and 15 scores
timeFrame: Prior 7 or 28 days
measure: Sexual Activity Log (SAL), orgasms
timeFrame: 1-7 day recall
measure: SAL proportion of sexual activities with orgasm
timeFrame: 1-7 day recall
measure: Sexual Activity Log (SAL) satisfying sexual events
timeFrame: 1-7 day recall
measure: Patient's Global Impression of Change
timeFrame: 4 weeks
Other outcomes:
measure: Safety: adverse events
timeFrame: 4-week recall
measure: pulse rate
timeFrame: one fourth to one half minute
measure: Blood pressure
timeFrame: one half minute or less
measure: Q-T interval
timeFrame: three heartbeats up to the number of heartbeats in 30 seconds
measure: Cardiac rate
timeFrame: 1/2 to 1 minute
measure: Columbia Suicide Severity Rating Scale, 6-item Screening/Triage version (C-SSRS-6)
timeFrame: prior 30 days
measure: Patient Health Questionnaire-9 Symptom Checklist (PHQ-9)
timeFrame: prior 2 weeks
Locations:
Study officials:
affiliation: S1 Biopharma, Inc.
name: Nicolas E Sitchon, B.S.
role: STUDY_CHAIR
References:
citation: 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.