Increasing sexual desire in men with low libido
Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
This study is testing if a medication called flibanserin can help men with low sexual desire feel more interested in sex.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | Male |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04002661 on ClinicalTrials.gov |
What this trial studies
This pilot randomized placebo-controlled study aims to evaluate the effectiveness of flibanserin in increasing sexual desire among men diagnosed with Hypoactive Sexual Desire Disorder (HSDD). A total of 60 male participants will be enrolled, with half receiving the active drug and the other half a placebo. Over approximately four months, participants will attend four study visits, during which they will undergo physical examinations, blood tests, and complete questionnaires to assess their sexual desire and overall well-being. The study seeks to determine if the treatment can alleviate distress related to low libido.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 to 69 who experience distress due to low libido but have good erectile function and normal testosterone levels.
Not a fit: Patients with hypogonadism or those with erectile dysfunction scores indicating poor erectile function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for men suffering from low libido and improve their quality of life.
How similar studies have performed: Previous studies have shown success with flibanserin in treating sexual desire disorders, indicating a potential for positive outcomes in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men age 18 through 69 years old * Men who 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 PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D) * Men with good erectile function as defined by IIEF greater than 22 * Men with normal testosterone and liver function values (may be on testosterone therapy) * 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 (less than 350 ng/dL) * IIEF-EF less than 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 the PHQ-9 questionnaire as defined as 10 or greater. * 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
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mohit Khera, MD, MBA, MPH — Baylor College of Medicine
- Study coordinator: Mohit Khera, MD, MBA, MPH
- Email: mkhera@bcm.edu
- Phone: 713-798-6593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.