Hypoactive Sexual Desire DisorderPhase 2NCT01432665
Lybrido for Female Sexual Dysfunction
A Phase 2 study testing Sildenafil and Testosterone in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 14 sites in United States.
Trial summary
The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Sildenafil and Testosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2011to May 2013
- 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 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Female 21 to 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional.
- Low sensitivity for sexual cues
- Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
- Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects > 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 90 mmHg
- Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg
- Use of oral contraceptive containing anti-androgens
Show all 36Show fewer
- Use of oral contraceptive containing 50 μg estrogen or more
- Positive test result for Chlamydia or gonorrhea
- Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women prior to the administration of study medications.)
- Lactating or delivery in the previous 6 months
- Significant abnormal pap smear in the previous 12 months
- History of bilateral oophorectomy
- Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- Liver and/or renal insufficiency (aspartate aminotransferase and alanine aminotransferase > 3 times the upper limit of normal and/or glomerular filtration rate < 29 mL/min based on the Cockcroft and Gault formula)
- Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
- Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for sildenafil and/or testosterone use
- History of hormone-dependent malignancy
- Vision impairment, such as partial or complete blindness or color blindness
- Dyslexia
- Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
- History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
- (Treatment for) a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil and/or testosterone use
- Current psychotherapeutic treatment for female sexual dysfunction
- Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
- A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study (Mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the home measurement [Stroop task].)
- Positive test result for illicit drugs
- Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole clarithromycin, erythromycin and saquinavir)
- Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St John"s wort, rifampin)
- Use of nitrates or nitric oxide donor compounds
- Use of selective serotonin reuptake inhibitors, tricyclic antidepressants, or other antidepressants
- Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid])
- Use of medication (including herbs) that would compromise the validity of study results
- Use of testosterone therapy within 6 months before study entry
- Illiteracy, unwillingness, or inability to follow study procedures
- Participation in other clinical trials within the last 30 days
- Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the participant"s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for sildenafil and/or testosterone use
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Annapolis Sexual Wellness Center
Annapolis, Maryland, 21401
Meridien Research
Brooksville, Florida, 34601
Segal Institute Women's Health Clinic
North Miami, Florida, 33161
Compass Research
Orlando, Florida, 32806
Philadelphia Clinical Research
Philadelphia, Pennsylvania, 19114
Women's Health Research Center
Plainsboro, New Jersey, 08536
Michael A. Werner, MD PC
Purchase, New York, 10577
San Diego Sexual Medicine
San Diego, California, 92120
Miami Research Associates
South Miami, Florida, 33143
Meridien Research
St. Petersburg, Florida, 34203
Maryland Prime Care Physicians
Stevensville, Maryland, 21666
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, 22104
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
About this study
The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Placebo, Sildenafil, Testosterone
- Keywords
- 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.
PlaceboDrug
Solid Oral Dosage. Maximum every other day (on an as needed basis)
SildenafilDrug
Solid Oral Dosage. Maximum every other day (on an as needed basis)
TestosteroneDrug
Solid Oral Dosage. Maximum every other day (on an as needed basis)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | 30 subjects administered a placebo Receives: Drug: Placebo |
| sildenafil + testosterone combination drug 1 | Experimental | 30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg) Receives: Drug: Sildenafil; Drug: Testosterone |
| Sildenafil and testosterone combination drug 2 | Experimental | Sildenafil 50mg and testosterone 0.25mg Receives: Drug: Sildenafil; Drug: Testosterone |
| Sildenafil and testosterone combination drug 3 | Experimental | 30 subjects are given sildenafil 25mg and testosterone 0.50mg Receives: Drug: Sildenafil; Drug: Testosterone |
| Sildenafil and Testosterone Combination drug 4 | Experimental | 30 subjects are given sildenafil 50mg and testosterone 0.50mg Receives: Drug: Sildenafil; Drug: Testosterone |
| Sildenafil 50mg | Experimental | 30 subjects are given sildenafil 50mg Receives: Drug: Sildenafil |
| Testosterone 0.50mg | Experimental | 30 subjects are given testosterone 0.5mg Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
Measured: 20 weeks
Secondary outcomes (4)
Sexual satisfaction
Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
Measured: 20 Weeks
Sexual desire and arousal
Sexual desire and arousal will be evaluated based on the 'desire' and 'arousal' domains of the Sexual Anamnesis Questionnaire, the Sexual Function questionnaire and weekly diaries throughout the course of the study.
Measured: 20 Weeks
Sexual motivation and inhibition
Sexual motivation and inhibition will be assessed using the Sexual Motivation Questionnaire and comparing sexual motivation and inhibition between the 4-week establishment period and the 8-week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
Measured: 20 Weeks
Safety and toleration
Safety will be evaluated by: 1) AEs [Number of patients reporting AEs, number of patients reporting drug related AEs] 2)SAE [Number of patients reporting SAEs, number of patients reporting drug related SAEs]and 3) Changes in laboratory safety data [Number of patients reporting abnormal lab safety data, number of patients reporting drug related abnormal lab safety data]. These will be evaluated throughout the course of the study.
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emotional Brain NY Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432665
- Sponsor's protocol ID
- EB82
- Status last verified
- Jul 2013
- First submitted
- 17 Aug 2011
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lybrido for Female Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT01432665
- Acronym / sponsor ID
- EB82
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- HSDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Emotional Brain NY Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- First posted
- 13 Sep 2011 (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.
The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo30 subjects administered a placebo |
| sildenafil + testosterone combination drug 1 | Experimental | Drug: Sildenafil, Drug: Testosterone30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg) |
| Sildenafil and testosterone combination drug 2 | Experimental | Drug: Sildenafil, Drug: TestosteroneSildenafil 50mg and testosterone 0.25mg |
| Sildenafil and testosterone combination drug 3 | Experimental | Drug: Sildenafil, Drug: Testosterone30 subjects are given sildenafil 25mg and testosterone 0.50mg |
| Sildenafil and Testosterone Combination drug 4 | Experimental | Drug: Sildenafil, Drug: Testosterone30 subjects are given sildenafil 50mg and testosterone 0.50mg |
| Sildenafil 50mg | Experimental | Drug: Sildenafil30 subjects are given sildenafil 50mg |
| Testosterone 0.50mg | Experimental | Drug: Testosterone30 subjects are given testosterone 0.5mg |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent
- Female 21 to 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional.
- Low sensitivity for sexual cues
- Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
- Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (36 listed)
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects > 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 90 mmHg
- Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg
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 |
|---|---|---|
| PlaceboSolid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Placebo |
| SildenafilSolid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Sildenafil 50mg, Sildenafil and Testosterone Combination drug 4, Sildenafil and testosterone combination drug 2, Sildenafil and testosterone combination drug 3, sildenafil + testosterone combination drug 1 |
| TestosteroneSolid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Sildenafil and Testosterone Combination drug 4, Sildenafil and testosterone combination drug 2, Sildenafil and testosterone combination drug 3, Testosterone 0.50mg, sildenafil + testosterone combination drug 1 |
Primary outcome
The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.
Time frame: 20 weeks
Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.
4 secondary outcomes
Sexual satisfaction
Time frame: 20 Weeks
Sexual desire and arousal
Time frame: 20 Weeks
Sexual motivation and inhibition
Time frame: 20 Weeks
Safety and toleration
Time frame: 20 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil and Testosterone in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 14 sites 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 5 inclusion and 36 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: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting. (time frame: 20 weeks). 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 29 Jul 2013.