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Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety

NCT01857596 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-28

No results posted yet for this 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.

Conditions

  • Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined)
  • Sexual Interest/Arousal Disorder (DSM-5 Defined)

Interventions

DRUG

bupropion, Lorexys low-dose, Lorexys moderate-dose

Lorexys is a proprietary fixed-dose combination of two agents

Sponsors & Collaborators

  • S1 Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert T Segraves, MD, PhD · Levine, Risen & Associates, Inc.

  • Molly Katz, MD · Katz and Kade, Inc.

  • Robert E Pyke, MD, PhD · Chief Medical Officer, S1 Biopharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857596 on ClinicalTrials.gov