Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Lybrido for Female Sexual Dysfunction

NCT01432665 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01432665

The ClinicalTrials.gov registry entry for NCT01432665 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emotional Brain NY, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01432665 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Florida, Maryland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01432665?

The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG), Sildenafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01432665?

This trial is sponsored by Emotional Brain NY, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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