Hypoactive Sexual Desire DisorderPhase 2NCT01743235
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
A Phase 2 study testing Testosterone and Buspirone hydrochloride in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 12 sites in United States.
Trial summary
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms. 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?
- Testosterone and Buspirone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2012to Jun 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
- Subjects must meet all of the following criteria:
- Provision of written informed consent
- Females between 21 and 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional.
- Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
- Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
- Healthy with normal 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
- Subjects who meet any of the following criteria are not eligible to participate in the study:
- Cardiovascular Conditions
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- 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. Gynecological and Obstetric Conditions
- Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
Show all 39Show fewer
- Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
- 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 of child bearing potential prior to the administration of study medications.)
- Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
- Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form
- History of bilateral oophorectomy
- Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms) Other Medical Conditions
- Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft-Gault formula)
- Any current endocrine disease or endocrinopathy (e.g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside normal range of the central laboratory; or uncontrolled diabetes mellitus (HbA1c > 7.5%)
- Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL)
- Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of buspirone and/or testosterone
- History of hormone-dependent malignancy (including all types of breast cancer)
- Vision impairment, such as partial or complete blindness or color blindness
- Dyslexia
- Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
- History of serotonin syndrome Psychological/Psychiatric Factors
- History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
- (Psychotherapeutic and/or pharmacological 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 buspirone 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 (DSM-IV-TR))
- 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 Stroop task).
- A score of > 65 at the STAI-Y2 questionnaire
- Positive test result for illicit drugs Concomitant Medications
- 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 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],spironolactone)
- Use of medication (including herbs) that would compromise the validity of study results
- Use of testosterone therapy within 6 months before study entry prior to signing the Informed Consent Form General
- 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 buspirone and/or testosterone use
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Annapolis Sexual Wellness Center
Annapolis, Maryland, 21401
Boston Clinical Trials
Boston, Massachusetts, 02135
Meridien Research
Bradenton, Florida, 34208
NECCR Fall River LLC
Fall River, Massachusetts, 02720
Segal Insitute for Clinical Research
North Miami, Florida, 33161
Compass Research
Orlando, Florida, 32806
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114
Michael A. Werner, MD PC
Purchase, New York, 10577
San Diego Sexual Medicine
San Diego, California, 92120
Meridien Research
St. Petersburg, Florida, 34203
Maryland Prime Care Physicians
Stevensville, Maryland, 21666
Center for Sexual Medicine at Sheppard Pratt
Townson, Maryland, 22104
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory Mechanisms
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.
In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested:
Read more
Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events.
The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.
Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Placebo, Testosterone, Buspirone hydrochloride
- 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)
TestosteroneDrug
Solid Oral Dosage. Maximum every other day (on an as needed basis)
Buspirone hydrochlorideDrug
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 |
| Testosterone + Buspirone hydrochloride combination drug | Experimental | 30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride) Receives: Drug: Testosterone; Drug: Buspirone hydrochloride |
| Testosterone + Buspirone hydrochloride combinat | Experimental | 30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride) Receives: Drug: Testosterone; Drug: Buspirone hydrochloride |
| Testosterone + Buspirone Combination Drug | Experimental | 30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride) Receives: Drug: Testosterone; Drug: Buspirone hydrochloride |
| Testosterone +Buspirone Combination Drug | Experimental | 30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride) Receives: Drug: Testosterone; Drug: Buspirone hydrochloride |
| Testosterone | Experimental | 30 subjects are given 0.5 mg Testosterone Receives: Drug: Testosterone |
| Buspirone | Experimental | 30 subjects are given 10 mg Buspirone hydrochloride Receives: Drug: Buspirone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory Sexual Episodes
To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder(HSDD) and maladaptive activity of sexual inhibitory mechanisms
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 posted6 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 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
- 207 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
- NCT01743235
- Sponsor's protocol ID
- EB90
- Other IDs
- EB90
- Status last verified
- Mar 2014
- First submitted
- 4 Dec 2012
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory Mechanisms
- ClinicalTrials.gov ID
- NCT01743235
- Acronym / sponsor ID
- EB90
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- HSDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Emotional Brain NY Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2012 (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.
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.
In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested:
Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events.
The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.
Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal.
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 |
| Testosterone + Buspirone hydrochloride combination drug | Experimental | Drug: Testosterone, Drug: Buspirone hydrochloride30 subjects are given combination drug (0.25 mg Testosterone + 5 mg Buspirone hydrochloride) |
| Testosterone + Buspirone hydrochloride combinat | Experimental | Drug: Testosterone, Drug: Buspirone hydrochloride30 subjects are given combination drug (0.25 mg Testosterone + 10 mg Buspirone hydrochloride) |
| Testosterone + Buspirone Combination Drug | Experimental | Drug: Testosterone, Drug: Buspirone hydrochloride30 subjects are given combination drug (0.5 mg Testosterone + 5 mg Buspirone hydrochloride) |
| Testosterone +Buspirone Combination Drug | Experimental | Drug: Testosterone, Drug: Buspirone hydrochloride30 subjects are given combination drug (0.5 mg Testosterone + 10 mg Buspirone hydrochloride) |
| Testosterone | Experimental | Drug: Testosterone30 subjects are given 0.5 mg Testosterone |
| Buspirone | Experimental | Drug: Buspirone hydrochloride30 subjects are given 10 mg Buspirone hydrochloride |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent
- Females between 21 and 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional.
- Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
- Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
- Healthy with normal 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 (39 listed)
- Subjects who meet any of the following criteria are not eligible to participate in the study:
- Cardiovascular Conditions
- Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- 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. Gynecological and Obstetric Conditions
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 |
| TestosteroneSolid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Testosterone, Testosterone + Buspirone Combination Drug, Testosterone + Buspirone hydrochloride combinat, Testosterone + Buspirone hydrochloride combination drug, Testosterone +Buspirone Combination Drug |
| Buspirone hydrochlorideSolid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Buspirone, Testosterone + Buspirone Combination Drug, Testosterone + Buspirone hydrochloride combinat, Testosterone + Buspirone hydrochloride combination drug, Testosterone +Buspirone Combination Drug |
Primary outcome
Satisfactory Sexual Episodes
Time frame: 20 Weeks
To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder(HSDD) and maladaptive activity of sexual inhibitory mechanisms
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 31 Mar 2014.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Testosterone and Buspirone hydrochloride in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 12 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 6 inclusion and 39 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 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Satisfactory Sexual Episodes (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 31 Mar 2014.