Orgasmic DisorderPhase 2NCT06516055
Study of S1B-408 in Women With Orgasmic Dysfunction
A Phase 2 study testing S1B-408 in people with Orgasmic Disorder, run by S1 Biopharma, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Orgasmic Disorder
- What is being tested?
- S1B-408
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- S1B-408
- Keywords
- S1B-408, Orgasmic Disorder, Female Sexual Dysfunction
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1B-408Drug
Medication with multiple monoamine activities
| Study group | Role | What they receive |
|---|---|---|
| S1B-408 | Experimental | One dose of S1B-408 with up-titration of one of its components after one week as needed and tolerated Receives: Drug: S1B-408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 or 28 day recall
Secondary outcomes (8)
Changes in Sexual Function Questionnaire (CSFQ): orgasm
sum of 3 items on orgasmic frequency, pleasure, and ability, each rated 1 (worst) to 5 (best)
Measured: 7 day recall
CSFQ total score
sum of 14 items on all aspects of female sexual response, scored from 14 to 70 (best)
Measured: "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)
Measured: 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)
Measured: Prior 7 or 28 days
Sexual Activity Log (SAL), orgasms
Sexual Activity Log count of orgasms
Measured: 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
Measured: 1-7 day recall
Sexual Activity Log (SAL) satisfying sexual events
Count of sexual events that were satisfying
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orgasmic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S1 Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas E Sitchon, B.S., Study chair, S1 Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516055
- Sponsor's protocol ID
- S1B-408-2000
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31678098
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Non-Blinded Study of Safety, Tolerability and Efficacy of S1B-408 in Women With Orgasmic Dysfunction
- ClinicalTrials.gov ID
- NCT06516055
- Acronym / sponsor ID
- S1B-408-2000
- Conditions
- Orgasmic Disorder
- Keywords
- S1B-408, Orgasmic Disorder, Female Sexual Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- S1 Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| S1B-408 | Experimental | Drug: S1B-408One dose of S1B-408 with up-titration of one of its components after one week as needed and tolerated |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1B-408Medication with multiple monoamine activities | Drug | S1B-408 |
Primary outcome
Female Sexual Function Index (FSFI): orgasm domain
Time frame: 7 or 28 day recall
sum of 3 items on orgasmic frequency, difficulty, and satisfaction, each rated 0 or 1 (worst) to 5 (best)
8 secondary outcomes
Changes in Sexual Function Questionnaire (CSFQ): orgasm
Time frame: 7 day recall
CSFQ total score
Time frame: "now" or 7 day recall
FSFI total score
Time frame: Prior 7 or 28 days
Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) items 13, 14, and 15 scores
Time frame: Prior 7 or 28 days
Sexual Activity Log (SAL), orgasms
Time frame: 1-7 day recall
SAL proportion of sexual activities with orgasm
Time frame: 1-7 day recall
Sexual Activity Log (SAL) satisfying sexual events
Time frame: 1-7 day recall
Patient's Global Impression of Change
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 31678098Pyke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas E Sitchon, B.S. study chair
S1 Biopharma, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1B-408 in people with Orgasmic Disorder, run by S1 Biopharma, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Clayton, MD (4342434649, AHC8V@hscmail.mcc.virginia), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI): orgasm domain (time frame: 7 or 28 day recall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.