Study of S1B-408 in Women With Orgasmic Dysfunction
NCT Number: NCT06516055
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Orgasmic Disorder
Interventions: DRUG: S1B-408
Sponsor: S1 Biopharma, Inc.
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-07-30

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.

Primary Outcome Measures: 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: 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: 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