drugset / Trial / NCT01432665

Lybrido for Female Sexual Dysfunction

NCT01432665

Phase 2 Completed 196 enrolled Emotional Brain NY Inc.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2011-09
Primary completion
2013-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 25 mg Oral
Subject Sildenafil Unknown 50 mg Oral
Subject Testosterone Small molecule 0.25 mg Oral
Subject Testosterone Small molecule 0.5 mg Oral