Hypoactive Sexual Desire DisorderPhase 3NCT03463707
BP101 for Adults With Female Sexual Dysfunction
A Phase 3 study testing BP101 in people with Hypoactive Sexual Desire Disorder and Female Sexual Dysfunction, run by Ivix LLX at 20 sites in Russia.
Trial summary
This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Female Sexual Dysfunction, Sexual Desire Disorder
- What is being tested?
- BP101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 20 sitesRussia
- Study dates
- 5 Mar 2018to 23 Jan 2019
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 21 to 50 years old, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3).
- Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the diagnosis of acquired generalized hypoactive sexual desire disorder (HSDD) according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
- Current HSDD episode lasting not less than 24 weeks.
- Not less than 15 scores according to the FSDS-R (Distress) Total Score.
- Stable monogamous relationship with one sexually active male sexual partner lasting at least a year. The partner is physically available not less than 50% of time during a month.
- Consent to attempt to have a sexual intercourse at least twice a month, if she has a desire.
- Consent to complete a diary every day during the screening period and assessment of the baseline state (in this period diary records must cover ≥80% days), during the therapy and subsequent follow-up.
- Consent to use adequate methods of contraception throughout the study.
Who cannot join
- Any prohibited treatments.
- Other mental disorders or psychiatric diseases.
- Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong.
- Score ≥ 20 according to the Beck Depression Inventory during the screening. Patients with 16 to 19 scores according to Beck's inventory may be included in the study unless, in the investigator's opinion, an actual depressive disorder is observed in the patient.
- Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.
- Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc), resulting in pain/dyspareunia, and/or precluding sexual contacts, and/or requires hormonal replacement treatment, and/or lead to the loss of sensibility while sexual contact.
- Pregnant and nursing women or non-lactating women during the first 12 months after childbirth.
- Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Russia20 sites
Алтайский государственный медицинский университет
Barnaul
Kazan State Medical University
Kazan'
Kuban State Medical University
Krasnodar
Central Clinical Hospital of the Russian Academy of Sciences
Moscow
N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
Moscow
National Medical Research Center of Obstetrics, Gynecology and Perinatology
Moscow
National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky
Moscow
Clinical Psychiatry Hospital №1
Nizhny Novgorod
Orenburg Regional Clinical Psychiatric Hospital No. 2
Orenburg
City psychiatric hospital №7 named after academician I.P. Pavlov
Saint Petersburg
Doctor SAN Ltd.
Saint Petersburg
Leningrad Regional Narcological Dispensary
Saint Petersburg
OrKli Hospital LLC
Saint Petersburg
Research center Eco-Safety LLC
Saint Petersburg
Samara Psychiatric Hospital
Samara
Regional Clinical Psychiatric Hospital of St. Sofia
Saratov
Engels Psycyatric hospital
Saratovskaya
Clinic "Hundred Years"
Tomsk
Bashkir State Medical University
Ufa
Yaroslavl Regional Clinical Psychiatric Hospital
Yaroslavl
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms.
- 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
Investigational product BP101, nasal spray
PlaceboDrug
Placebo to Investigational product BP101, nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BP101 | Experimental | Not described Receives: Drug: BP101 |
| Treatment with placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfying sexual events
Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 weeks of treatment, compared with the baseline.
Measured: Baseline and 4 weeks of treatment
Secondary outcomes (14)
Satisfying sexual events
Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 and 8 weeks of follow-up, compared with the baseline.
Measured: Baseline and 4 and 8 weeks of follow-up
Orgasms
Change in the number of orgasms, standardized to the 28-day period, after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index total score
Change in the Female Sexual Function Index (FSFI) total score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI total score ranges from 2.0 to 36.0, where higher score represents better sexual function. FSFI total score is a sum of FSFI individual domains scores (individual domains are: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain).
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Desire domain score
Change in the Female Sexual Function Index (FSFI) Desire domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Desire domain score ranges from 1.2 to 6.0, where higher score represents better sexual desire.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Arousal domain score
Change in the Female Sexual Function Index (FSFI) Arousal domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Arousal domain score ranges from 0 to 6.0, where higher score represents better sexual arousal.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Lubrication domain score
Change in the Female Sexual Function Index (FSFI) Lubrication domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Lubrication domain score ranges from 0 to 6.0, where higher score represents better vaginal lubrication.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Orgasm domain score
Change in the Female Sexual Function Index (FSFI) Orgasm domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Orgasm domain score ranges from 0 to 6.0, where higher score represents better orgasm sensation.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Satisfaction domain score
Change in the Female Sexual Function Index (FSFI) Satisfaction domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Satisfaction domain score ranges from 0.8 to 6.0, where higher score represents better sexual satisfaction.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Pain domain score
Change in the Female Sexual Function Index (FSFI) Pain domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSFI Pain domain score ranges from 0 to 6.0, where higher score represents lower pain sensation during sexual intercourse.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Distress Scale-Revised Total score
Change in the Female Sexual Distress Scale-Revised (FSDS-R) total score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSDS-R total score ranges from 0 to 52, where higher score represents higher level of distress related to sexual activities. A score of ≥11 discriminates between women with female sexual disfunction (score of ≥11) and no female sexual disfunction (score of <11).
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Distress Scale-Revised Item 13 score
Change in the Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSDS-R Item 13 score ranges from 0 to 4, where higher score represents higher level of bother by low sexual desire.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Sexual function according to the Female Sexual Function questionnaire
Change in the Female Sexual Function questionnaire (FSF) score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
FSF score ranges from 0 to 36, where higher score represents better sexual function.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement
The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement (PGI-I) after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline.
Measured: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Number of adverse events
Frequency of adverse events reporting, including serious adverse events, in treatment groups.
Measured: During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start5 Mar 2018
- Primary completion26 Nov 2018
- Study completion23 Jan 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivix LLX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniil G. Nemenov, MD, Study director, Ivix LLX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463707
- Sponsor's protocol ID
- BP101-SD02-RUS
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2018
- 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
- Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
- ClinicalTrials.gov ID
- NCT03463707
- Acronym / sponsor ID
- BP101-SD02-RUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Ivix LLXIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 13 Mar 2018 (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.
This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms.
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 |
|---|---|---|
| Treatment with BP101 | Experimental | Drug: BP101 |
| Treatment with placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged from 21 to 50 years old, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3).
- Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the diagnosis of acquired generalized hypoactive sexual desire disorder (HSDD) according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
- Current HSDD episode lasting not less than 24 weeks.
- Not less than 15 scores according to the FSDS-R (Distress) Total Score.
- Stable monogamous relationship with one sexually active male sexual partner lasting at least a year. The partner is physically available not less than 50% of time during a month.
Key exclusion criteria (8 listed)
- Any prohibited treatments.
- Other mental disorders or psychiatric diseases.
- Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong.
- Score ≥ 20 according to the Beck Depression Inventory during the screening. Patients with 16 to 19 scores according to Beck's inventory may be included in the study unless, in the investigator's opinion, an actual depressive disorder is observed in the patient.
- Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.
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 |
|---|---|---|
| BP101Investigational product BP101, nasal spray | Drug | Treatment with BP101 |
| PlaceboPlacebo to Investigational product BP101, nasal spray | Drug | Treatment with placebo |
Primary outcome
Satisfying sexual events
Time frame: Baseline and 4 weeks of treatment
Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 weeks of treatment, compared with the baseline.
14 secondary outcomes
Satisfying sexual events
Time frame: Baseline and 4 and 8 weeks of follow-up
Orgasms
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index total score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Desire domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Arousal domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Lubrication domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Orgasm domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Satisfaction domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Function Index Pain domain score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Distress Scale-Revised Total score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Female Sexual Distress Scale-Revised Item 13 score
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Sexual function according to the Female Sexual Function questionnaire
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement
Time frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Number of adverse events
Time frame: During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up)
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
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.
Daniil G. Nemenov, MD study director
Ivix LLX
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BP101 in people with Hypoactive Sexual Desire Disorder and Female Sexual Dysfunction, run by Ivix LLX at 20 sites 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 8 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 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Satisfying sexual events (time frame: Baseline and 4 weeks of treatment). 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.