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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 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. The trial reports 2 study locations across 1 state.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2013-04
Est. Completion 2014-10
Phase Phase 1

Sponsor

S1 Biopharma

1 total trials

What the Registry Record Tells You About NCT01857596

The ClinicalTrials.gov registry entry for NCT01857596 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is S1 Biopharma, which has 1 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.