Baylor College of Medicine

Hypoactive Sexual Desire Disorder in Men Study (H-44634)

Description

Content

This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night.

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD.

Eligibility Criteria

Inclusion criteria

  • Men age 18 through 69 years old
  • Men that are distressed by their low libido as defined by SDI-2 and SCI-M questionnaires. (Appendices A-C)
  • Men who are not depressed as defined by a PHQ-9 (Patient Health Questionnaire) score of ≤9. (Appendices D)
  • Men with good erectile function as defined by IIEF-EF >22
  • Men with normal testosterone and liver function values (may be on TTh)
  • Men who are satisfied in their relationship or with their partners
  • Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.
  • Willing to give informed consent

Exclusion criteria

  • Hypogonadal patients (<350 ng/dL)
  • SDI-2 ≥24
  • IIEF-EF <22
  • CYP3A4 and CYP2C19 inhibitors: Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor
  • Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
  • Men with normal to high libido
  • Depressed patients as assessed by a PHQ-9 questionnaire score of ≥10
  • Men who are stressed or fatigued as determined by the PI
  • Men with partners who have low libido as determined by the PI
  • Men with pre-existing conditions that might predispose to hypertension
  • Men who are not willing to meet the requirements for drinking alcohol during their participation in the study.
  • Men who are taking digoxin.

Contact

Haarika Gudlavalleti

Phone 1: 713–798–8514

IRB: H-44634

Status:

Active

Created:

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