Low LibidoPhase 2HSDDNCT04002661
Hypoactive Sexual Desire Disorder in Males
A Phase 2 study testing Flibanserin in people with Low Libido, run by Mohit Khera at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 69 years, men only
- Conditions the study is for
- Low Libido
- What is being tested?
- Flibanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to 23 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
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).
Read the detailed description
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
- Low Libido
- Being tested
- Flibanserin, Placebo
- Keywords
- Low libido, Erectile Dysfunction, Sexual desire
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlibanserinDrug
Also called Addyi
Flibanserin tablet
PlaceboDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Active | Active comparator | Participants will take flibanserin 100mg orally every night for approximately 3 months. Receives: Drug: Flibanserin |
| Arm 2 - Placebo | Placebo comparator | Participants will take a placebo orally every night for approximately 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Desires Inventory-2 (SDI-2)
Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
Measured: 3 months
Patient Health Questionnaire (PHQ-9)
Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months
Measured: 3 months
Secondary outcomes (2)
Erectile Function Change
Number of Participants with a significant change in erectile function and orgasmic scores of at least 2 points on the International Index of Erectile Function (Questions 2, 11, and 12) domain is considered to be 2 points higher than at screening
Measured: 3 months
Sexual Concerns Inventory - Male (SCI-M) questionnaire
Number of Participants with a significant change of at least 2 points higher than at screening.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start8 May 2020
- Primary completion31 Oct 2025
- Study completion23 Jan 2026
Why it stopped: The study's inclusion and exclusion criteria are tight and could not enroll any patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low LibidoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 will receive investigational product. Arm 2 will receive placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohit Khera
- Sponsor type
- University, hospital or other
- Collaborators
- Sprout Pharmaceuticals, Inc
- Responsible party
- Sponsor-investigator, Mohit Khera, Baylor College of Medicine
- Investigators
- Mohit Khera, MD, MBA, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002661
- Sponsor's protocol ID
- H-44634
- Acronym
- HSDD
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2019
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant date for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
- ClinicalTrials.gov ID
- NCT04002661
- Acronym / sponsor ID
- HSDD / H-44634
- Conditions
- Low Libido
- Keywords
- Low libido, Erectile Dysfunction, Sexual desire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study's inclusion and exclusion criteria are tight and could not enroll any patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mohit KheraUniversity, hospital or other
- Collaborators
- Sprout Pharmaceuticals, Inc
- Study start
- 8 May 2020 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Arm 1 will receive investigational product. Arm 2 will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Active | Active comparator | Drug: FlibanserinParticipants will take flibanserin 100mg orally every night for approximately 3 months. |
| Arm 2 - Placebo | Placebo comparator | Drug: PlaceboParticipants will take a placebo orally every night for approximately 3 months. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlibanserinAlso: AddyiFlibanserin tablet | Drug | Arm 1 - Active |
| PlaceboOral Tablet | Drug | Arm 2 - Placebo |
Primary outcome
Sexual Desires Inventory-2 (SDI-2)
Time frame: 3 months
Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
Patient Health Questionnaire (PHQ-9)
Time frame: 3 months
Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months
2 secondary outcomes
Erectile Function Change
Time frame: 3 months
Sexual Concerns Inventory - Male (SCI-M) questionnaire
Time frame: 3 months
Results and safety
The study was stopped early (reason given: The study's inclusion and exclusion criteria are tight and could not enroll any patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. De-identified individual participant date for all primary and secondary outcome measures will be made available.
Related trials for Low Libido
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Khera, MD, MBA, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flibanserin in people with Low Libido, run by Mohit Khera at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study's inclusion and exclusion criteria are tight and could not enroll any patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Desires Inventory-2 (SDI-2) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.