Hypoactive Sexual Desire DisorderPhase 4NCT02714049
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
A Phase 4 study testing sex therapy and flibanserin in people with Hypoactive Sexual Desire Disorder, run by San Diego Sexual Medicine at 1 site in United States.
Trial summary
Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- sex therapy and flibanserin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 30 Jan 2019
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is female;
- Subject is ≥18 years old;
- Subject has biologic-based HSDD as her primary sexual complaint;
- Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
- Subject scores >18 on FSDS-DAO;
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- Subject answers yes to questions 1-4 on the DSDS screener;
- Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
- Subject agrees to comply with the study procedures and visits.
Who cannot join
- Subject has sexual pain;
- Subject does not have generalized, acquired HSDD;
- Subject has used flibanserin in the last 6 months;
- Subject has history of alcohol or drug abuse;
- Subject uses tobacco in any form;
- Subject is currently using androgen therapy and unwilling to washout;
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- Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
- Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
- Subject is taking a CYP3A4 inducer;
- P-glycoprotein substrate;
- Subject has a history of liver impairment;
- Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official title: Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.
Read the detailed description
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- sex therapy, flibanserin
- Keywords
- hypoactive sexual desire disorder, Addyi, flibanserin, low sexual desire, HSDD
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sex therapyBehavioural
Also called psychotherapy
60 minutes each time, in person or on the telephone
flibanserinDrug
Also called Addyi
FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women
| Study group | Role | What they receive |
|---|---|---|
| flibanserin | Experimental | Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug Receives: Drug: flibanserin |
| flibanserin and sex therapy | Experimental | Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits Receives: Behavioral: sex therapy; Drug: flibanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desire domain of the Female Sexual Function Index (FSFI)
The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication.
Measured: at weeks 8 and 20
Secondary outcomes (2)
Female Sexual Distress Scale (FSDS-DAO)
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the Female Sexual Distress Scale (FSDS-DAO) in women who respond to the study medication.
Measured: at weeks 8 and 20
Total score of the Female Sexual Function Index (FSFI)
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the total FSFI score respectively in women who respond to the study medication.
Measured: at weeks 8 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start25 Jan 2017
- Primary completion18 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Investor Initiated Grant support stopped when drug was sold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego Sexual Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irwin Goldstein, MD, Principal investigator, San Diego Sexual Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714049
- Sponsor's protocol ID
- SDSM-2015-03
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2016
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
- ClinicalTrials.gov ID
- NCT02714049
- Acronym / sponsor ID
- SDSM-2015-03
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- hypoactive sexual desire disorder, Addyi, flibanserin, low sexual desire, HSDD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investor Initiated Grant support stopped when drug was sold.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- San Diego Sexual MedicineUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 21 Mar 2016 (estimated)
- 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.
Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.
Detailed description
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flibanserin | Experimental | Drug: flibanserinSubjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug |
| flibanserin and sex therapy | Experimental | Behavioral: sex therapy, Drug: flibanserinSubjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is female;
- Subject is ≥18 years old;
- Subject has biologic-based HSDD as her primary sexual complaint;
- Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
Key exclusion criteria (13 listed)
- Subject has sexual pain;
- Subject does not have generalized, acquired HSDD;
- Subject has used flibanserin in the last 6 months;
- Subject has history of alcohol or drug abuse;
- Subject uses tobacco in any form;
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 |
|---|---|---|
| sex therapyAlso: psychotherapy60 minutes each time, in person or on the telephone | Behavioural | flibanserin and sex therapy |
| flibanserinAlso: AddyiFDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women | Drug | flibanserin, flibanserin and sex therapy |
Primary outcome
Desire domain of the Female Sexual Function Index (FSFI)
Time frame: at weeks 8 and 20
The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication.
2 secondary outcomes
Female Sexual Distress Scale (FSDS-DAO)
Time frame: at weeks 8 and 20
Total score of the Female Sexual Function Index (FSFI)
Time frame: at weeks 8 and 20
Results and safety
The study was stopped early (reason given: Investor Initiated Grant support stopped when drug was sold.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Clinical trials at San Diego Sexual MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypoactive Sexual Desire Disorder
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Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
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.
Irwin Goldstein, MD principal investigator
San Diego Sexual Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sex therapy and flibanserin in people with Hypoactive Sexual Desire Disorder, run by San Diego Sexual Medicine 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 9 inclusion and 13 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 13 Jun 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Investor Initiated Grant support stopped when drug was sold.). 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?
Desire domain of the Female Sexual Function Index (FSFI) (time frame: at weeks 8 and 20). 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 13 Jun 2022.