NCT01432665

Lybrido for Female Sexual Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Emotional Brain NY Inc. · Industry
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-05-01
• First posted: 2011-09-13
• Last updated: 2013-07-29

Locations

14 sites across 1 country: United States