Hypoactive Sexual Desire Disorder in Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2026-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

NCT02714049

Hypoactive Sexual Desire Disorder

TERMINATED PHASE4

Lybrido for Female Sexual Dysfunction

NCT01432665

Hypoactive Sexual Desire Disorder

COMPLETED PHASE2

Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

NCT00141349

Impotence

COMPLETED PHASE2

Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men

NCT06571318

Premature Ejaculation Stress

NOT_YET_RECRUITING NA

A Study in Erectile Dysfunction

NCT00833638

Erectile Dysfunction

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

There will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Libido

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1 will receive investigational product.

Arm 2 will receive placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study medication (flibanserin 100 mg or identically matched placebo) will be provided in a randomized fashion. Randomization will be 1:1 with a block size of 4. Each individual kit will contain three bottles of 30 tablets of study medication. Each individual bottle within the kit will be labeled sequentially, for example kit 201 will include three bottles of 30 tablets labeled 201A, 201B, 201C. Kits will be numbered consecutively in the randomized order. Once a patient is confirmed eligible to participate in the study, the site will select the lowest numbered kit that has not been assigned to a subject. Subjects will be provided with the "A" bottle at their first visit. The site will mark the subject's study number on the kit and document which subject received that kit number. As subjects return for interim visits, they will be provided the "B" and "C" bottles from their previously assigned kit.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 - Active

Participants will take flibanserin 100mg orally every night for approximately 3 months.

Group Type ACTIVE_COMPARATOR

Flibanserin

Intervention Type DRUG

Flibanserin tablet

Arm 2 - Placebo

Participants will take a placebo orally every night for approximately 3 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flibanserin

Flibanserin tablet

Intervention Type DRUG

Placebo

Oral Tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Addyi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No