Hypoactive Sexual Desire Disorder(HSDD)Phase 1NCT03102489
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
A Phase 1 study testing BP101 in people with Hypoactive Sexual Desire Disorder(HSDD), run by Ivix LLX at 1 site in Russia.
Trial summary
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder(HSDD)
- What is being tested?
- BP101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteRussia
- Study dates
- 22 Feb 2017to 19 Sep 2017
- Phase
- Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged from 18 to 40, inclusive.
- Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
- Body mass index (BMI) within range from 18.5 to 30 kg/m^2.
- Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
- Negative pregnancy test result at screening and before start of Investigational Product administration.
- Consent to use adequate methods of contraception throughout the study.
- Normal regular menstrual cycle of 28 +/- 7 days duration for at least 6 months before study enrollment.
- Women with stable sexual partner.
Who cannot join
- Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
- Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
- Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
- Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
- Electrocardiogram (ECG) abnormalities at screening, and before start of Investigational Product administration.
- Systolic blood pressure in a sitting position below 100 mm Hg or above 140 mm Hg; and/or diastolic pressure below 60 mm Hg or above 90 mm Hg at screening and before start of Investigational Product administration.
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- Heart rate less than 60 beats/min or more than 90 beats/min at screening, and before start of Investigational Product administration.
- Signs of malignant neoplasms in medical history, during the examination at any time prior to start of Investigational Product administration.
- Psychiatric disorders (including any form of schizophrenia, epilepsy, bipolar affective disorder and others), intake of psychotropic agents.
- Chronic pain syndromes (including chronic pelvic pain syndrome).
- Acute infections within 4 weeks before screening.
- Regular intake of medications (including nonprescription drugs, vitamins, and Supplements) within 2 weeks before screening.
- Intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liter of beer, 200 ml wine or 30 ml of spirit (pure alcohol)) or historical information about alcoholism, substance abuse, prescription drug abuse.
- Smoking more than 10 cigarettes a day.
- Pregnancy or breastfeeding, positive urine pregnancy at screening and before the start of Investigational Product administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
Read the detailed description
Double-blind, randomized, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy volunteers.
- Conditions
- Hypoactive Sexual Desire Disorder(HSDD)
- Being tested
- BP101, Placebo
- 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.
BP101Drug
Nasal spray
PlaceboDrug
Nasal spray
| Study group | Role | What they receive |
|---|---|---|
| BP101 | Experimental | Treatment with BP101 Receives: Drug: BP101 |
| Placebo | Placebo comparator | Treatment with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent Adverse Events
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
Measured: 6 weeks
Secondary outcomes (12)
BP101 maximum plasma concentration (Cmax)
To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.
Measured: Day 1
BP101 area under the concentration versus time curve (AUC)
To determine pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) after single administration of BP101 in healthy volunteers.
Measured: Day 1
BP101 time to maximum plasma concentration (Tmax)
To determine pharmacokinetic parameter time to maximum plasma concentration (Tmax) after single administration of BP101 in healthy volunteers.
Measured: Day 1
BP101 half-life time (T1/2)
To determine pharmacokinetic parameter of plasma half-life time (T1/2) after single administration of BP101 in healthy volunteers.
Measured: Day 1
Change from Baseline in Female Sexual Function Index score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Measured: 2 weeks
Change from Baseline in Female Sexual Function Index score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Measured: 6 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Measured: 2 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Measured: 6 weeks
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Measured: 2 weeks
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Measured: 6 weeks
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Measured: 2 weeks
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start22 Feb 2017
- Primary completion21 Jun 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire Disorder(HSDD)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivix LLX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniil Nemenov, M.D., Study director, Ivix LLX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102489
- Sponsor's protocol ID
- BP101-HV02
- Status last verified
- Feb 2020
- First submitted
- 13 Mar 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03102489
- Acronym / sponsor ID
- BP101-HV02
- Conditions
- Hypoactive Sexual Desire Disorder(HSDD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ivix LLXIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 5 Apr 2017 (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.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
Detailed description
Double-blind, randomized, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP101 | Experimental | Drug: BP101Treatment with BP101 |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women aged from 18 to 40, inclusive.
- Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
- Body mass index (BMI) within range from 18.5 to 30 kg/m^2.
- Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
- Negative pregnancy test result at screening and before start of Investigational Product administration.
Key exclusion criteria (15 listed)
- Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
- Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
- Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
- Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
- Electrocardiogram (ECG) abnormalities at screening, and before start of Investigational Product administration.
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 |
|---|---|---|
| BP101Nasal spray | Drug | BP101 |
| PlaceboNasal spray | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent Adverse Events
Time frame: 6 weeks
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
12 secondary outcomes
BP101 maximum plasma concentration (Cmax)
Time frame: Day 1
BP101 area under the concentration versus time curve (AUC)
Time frame: Day 1
BP101 time to maximum plasma concentration (Tmax)
Time frame: Day 1
BP101 half-life time (T1/2)
Time frame: Day 1
Change from Baseline in Female Sexual Function Index score
Time frame: 2 weeks
Change from Baseline in Female Sexual Function Index score
Time frame: 6 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
Time frame: 2 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
Time frame: 6 weeks
Change from Baseline in Female Sexual Function questionnaire score
Time frame: 2 weeks
Change from Baseline in Female Sexual Function questionnaire score
Time frame: 6 weeks
Change from Baseline in Arizona Sexual Experience Scale score
Time frame: 2 weeks
Change from Baseline in Arizona Sexual Experience Scale score
Time frame: 6 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 11 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Hypoactive Sexual Desire Disorder(HSDD)
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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.
Daniil Nemenov, M.D. study director
Ivix LLX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP101 in people with Hypoactive Sexual Desire Disorder(HSDD), run by Ivix LLX at 1 site in Russia.
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 15 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 11 Feb 2020. 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 Russia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of treatment-emergent Adverse Events (time frame: 6 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 11 Feb 2020.