Treatment for Libido decreased

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Baylor College of Medicine, Houston, TX
Libido decreased+1 More
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help increase sexual desire in men with hypoactive sexual desire disorder.

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Eligible Conditions

  • Libido decreased

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 2 secondary outcomes in patients with Libido decreased. Measurement will happen over the course of 3 months.

3 months
Erectile Function Change
Patient Health Questionnaire (PHQ-9)
Sexual Concerns Inventory - Male (SCI-M) questionnaire
Sexual Desires Inventory-2 (SDI-2)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm 1 - Active
1 of 2
Arm 2 - Placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 1 - Active
Drug
Participants will take flibanserin 100mg orally every night for approximately 3 months.
Arm 2 - Placebo
Drug
Participants will take a placebo orally every night for approximately 3 months.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Closest Location

Baylor College of Medicine - Houston, TX

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Libido decreased by sharing your contact details with the study coordinator.