Hypoactive Sexual Desire DisorderPhase 2NCT02101203
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 2 study testing 0.5 mgTestosterone + 10 mg Buspirone in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 10 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?
- 0.5 mgTestosterone + 10 mg Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2013to Oct 2014
- 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 4 for definition)
- 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
- 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 anti-androgens (e.g. Cyproteron acetate) or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
Show all 17Show 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 the 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Annapolis Sexual Wellness Center
Annapolis, Maryland, 21401
Meridien Research
Bradenton, Florida, 34208
NECCR Fall River LLC
Fall River, Massachusetts, 02720
Maryland Center for Sexual Wellness
Lutherville, Maryland, 21093
Compass Research
Orlando, Florida, 32806
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19224
Maryland Primary Care Physicians
Queenstown, Maryland, 21658
San Diego Sexual Medicine
San Diego, California, 92120
Meridien Research
St. Petersburg, Florida, 33709
Comprehensive Clinical Trials LLC
West Palm Beach, Florida, 33409
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.
This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).
Read more
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.
Objectives:
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
- To identify the optimal dose of Lybridos to take into phase 3 clinical development
- To confirm that Lybridos has superior efficacy as compared to testosterone alone and to buspirone alone
- To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or sexual desire/arousal
- To evaluate the safety profile of Lybridos
Read the detailed description
None entered
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Placebo, 0.5 mgTestosterone + 10 mg Buspirone
- 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
Also called Solid Oral Dosage. Maximum every other day (on an as needed basis)
0.5 mgTestosterone + 10 mg BuspironeDrug
Also called Solid Oral Dosage. Maximum every other day (on an as needed basis)
A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | 40 subjects administered placebo Receives: Drug: Placebo |
| Testosterone + Buspirone | Experimental | 40 subjects administered 0.5 mg Testosterone + 10 mg Buspirone hydrochloride Receives: Drug: 0.5 mgTestosterone + 10 mg Buspirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).
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
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 Distress
Sexual Distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).
Measured: 20 weeks
Subjective evaluation of gain and improvement
Using the following tools, perceived gain and improvement will be assessed:
- Subjective Evaluation of Gain (SEG)
- Subjective Evaluation of Improvement (SEI)
- Patient's Global Impression of Improvement (PGI-I)
- Patient Benefit Evaluation (PBE)
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 posted2 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionOct 2014
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
- 80 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
- NCT02101203
- Sponsor's protocol ID
- EB90a extension
- Status last verified
- Mar 2014
- First submitted
- 28 Mar 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. 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
- NCT02101203
- Acronym / sponsor ID
- EB90a extension
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- HSDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emotional Brain NY Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Apr 2014 (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.
This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).
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.
Objectives:
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
- To identify the optimal dose of Lybridos to take into phase 3 clinical development
- To confirm that Lybridos has superior efficacy as compared to testosterone alone and to buspirone alone
- To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or sexual desire/arousal
- To evaluate the safety profile of Lybridos
Detailed description
None entered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo40 subjects administered placebo |
| Testosterone + Buspirone | Experimental | Drug: 0.5 mgTestosterone + 10 mg Buspirone40 subjects administered 0.5 mg Testosterone + 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 4 for definition)
- 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 (17 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 |
|---|---|---|
| PlaceboAlso: Solid Oral Dosage. Maximum every other day (on an as needed basis) | Drug | Placebo |
| 0.5 mgTestosterone + 10 mg BuspironeAlso: Solid Oral Dosage. Maximum every other day (on an as needed basis)A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days). | Drug | Testosterone + Buspirone |
Primary outcome
The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).
Time frame: 20 weeks
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.
4 secondary outcomes
Sexual Satisfaction
Time frame: 20 weeks
Sexual desire and arousal
Time frame: 20 weeks
Sexual Distress
Time frame: 20 weeks
Subjective evaluation of gain and improvement
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 24 Mar 2015.
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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.
10 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 0.5 mgTestosterone + 10 mg Buspirone in people with Hypoactive Sexual Desire Disorder, run by Emotional Brain NY Inc. at 10 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 17 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ). (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 24 Mar 2015.