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NCT01857596 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
A Phase 1 study of Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined), sponsored by S1 Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT01857596: Completed Phase 1 study of Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined), sponsored by S1 Biopharma.
NCT01857596 is a Phase 1 study of Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined) that has completed, run by S1 Biopharma. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01857596, a Phase 1 study of Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined), has completed, sponsored by S1 Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree.
Primary Outcome
One item asks how often the subject feels sexual desire, and another item asks how much she feels desire. One of five answers must be checked for each item.
Conditions Studied
Interventions
- DRUG bupropion, Lorexys low-dose, Lorexys moderate-dose
Study Locations (2)
Ohio
- Robert Taylor Segraves, MD, PhD - Beachwood
- Molly Katz, MD - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01857596 record still lists
NCT01857596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) appearing as the primary indexed condition, and to 1 intervention - of which bupropion, Lorexys low-dose, Lorexys moderate-dose is the first listed.
NCT01857596 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01857596 about?
NCT01857596 is a clinical study titled "Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety". The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree.
What is the current status of trial NCT01857596?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-04. Estimated completion is 2014-10.
What conditions does trial NCT01857596 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined).
What interventions are being tested in trial NCT01857596?
The interventions under investigation include: bupropion, Lorexys low-dose, Lorexys moderate-dose (DRUG).
Who is sponsoring clinical trial NCT01857596?
This trial is sponsored by S1 Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01857596 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01857596's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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