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Lybrido for Female Sexual Dysfunction

NCT01432665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2013-07-29

No results posted yet for this 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).

Conditions

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

Placebo

Solid Oral Dosage. Maximum every other day (on an as needed basis)

DRUG

Sildenafil

Solid Oral Dosage. Maximum every other day (on an as needed basis)

DRUG

Testosterone

Solid Oral Dosage. Maximum every other day (on an as needed basis)

Sponsors & Collaborators

  • Emotional Brain NY Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01432665 on ClinicalTrials.gov