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NCT01432665 · ClinicalTrials.gov registry record · Phase 2

Lybrido for Female Sexual Dysfunction

A Phase 2 study of Hypoactive Sexual Desire Disorder, sponsored by Emotional Brain NY.

Completed
Registry status
Phase 2
Development phase
196
Enrollment target
14
Study locations

NCT01432665 is a Phase 2 study of Hypoactive Sexual Desire Disorder that has completed, run by Emotional Brain NY. The registered enrollment target is 196 participants, below the 380-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (48% lower). The trial reports 14 study locations across 7 states.

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The verdict

NCT01432665, a Phase 2 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by Emotional Brain NY.

COMPLETED
Registry status
Phase 2
Development phase
196 participants
Enrollment target
14
Study locations

Study Summary

The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).

Interventions

  • DRUG Placebo
  • DRUG Testosterone
  • DRUG Sildenafil

Study Locations (14)

Florida

  • Meridien Research - Brooksville
  • Segal Institute Women's Health Clinic - North Miami
  • Compass Research - Orlando
  • Miami Research Associates - South Miami
  • Meridien Research - St. Petersburg
  • Comprehensive Clinical Trials, LLC - West Palm Beach

Maryland

  • Annapolis Sexual Wellness Center - Annapolis
  • Maryland Prime Care Physicians - Stevensville
  • Center for Sexual Medicine at Sheppard Pratt - Townson

California

  • San Diego Sexual Medicine - San Diego

District of Columbia

  • The Center for Vulvovaginal Disorders - Washington D.C.

New Jersey

  • Women's Health Research Center - Plainsboro

New York

  • Michael A. Werner, MD PC - Purchase

Pennsylvania

  • Philadelphia Clinical Research - Philadelphia

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2011-09
Phase Phase 2

Sponsor

Emotional Brain NY

3 total trials

What the Registry Record Tells You About NCT01432665

The ClinicalTrials.gov registry entry for NCT01432665 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (48% lower). The listed sponsor is Emotional Brain NY, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01432665 reports 14 study locations spanning 7 distinct geographic areas - top geographies include Florida, Maryland, California.

Frequently Asked Questions

What is clinical trial NCT01432665 about?

NCT01432665 is a clinical study titled "Lybrido for Female Sexual Dysfunction". The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of ...

What is the current status of trial NCT01432665?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2011-09.

What conditions does trial NCT01432665 study?

This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.

What interventions are being tested in trial NCT01432665?

The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG), Sildenafil (DRUG).

Who is sponsoring clinical trial NCT01432665?

This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01432665 being conducted?

This trial has 14 study locations across California, District of Columbia, Florida, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.