Hypoactive Sexual Desire Disorder (HSDD)Phase 2NCT03080298
Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
A Phase 2 study testing BP101 in people with Hypoactive Sexual Desire Disorder (HSDD), run by Ivix LLX at 12 sites in Russia.
Trial summary
This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- 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
- 119 participants
- Where
- 12 sitesRussia
- Study dates
- 14 Mar 2016to 25 Jul 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 21 or older, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3 (see Annex 7)).
- The level of follicle-stimulating hormone (FSH) is not more than 25 milli-International unit per ml (mIU/ml) according to the screening values.
- Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the hypoactive sexual desire disorder (HSDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
- Current HSDD episode lasting not less than 24 weeks.
- Patients with secondary female sexual arousal disorder (FSAD) and/or female orgasmic disorder (FOD) will be eligible only if the HSDD developed before the FSAD and/or FOD and the HSDD has a more significant impact on the patient's quality of life.
- Not less than 15 scores according to the FSDS-R (Distress) Total Score.
Show all 10Show fewer
- 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.
- 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.
- Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc).
- 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
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
V.M. Bekhterev Republic Clinical Psychiatric Hospital
Kazan'
"People's Friendship University of Russia"
Moscow
Mental Health Research Center
Moscow
N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
Moscow
Clinical Psychiatry Hospital №1
Nizhny Novgorod
Orenburg Regional Clinical Psychiatric Hospital #1
Orenburg
OrKli Hospital LLC
Saint Petersburg
Regional Clinical Psychiatric Hospital of St. Sofia
Saratov
Engels Psycyatric hospital
Saratov Oblast
Clinic "Hundred Years"
Tomsk
Yaroslavl Regional Clinical Psychiatric Hospital
Yaroslavl
Sverdlovsk Regional Clinical Psychiatric Hospital
Yekaterinburg
About this study
Official title: International, Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2a Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.
- 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
PlaceboDrug
| 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.
Desire domain score in the Female Sexual Function Index
Change in the Desire domain score in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of treatment compared with the baseline.
Measured: 28 days (4 weeks) of treatment
Item 13 score in the Female Sexual Distress Scale-Revised
Change of Item 13 score in the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) of treatment compared with the baseline.
Measured: 28 days (4 weeks) of treatment
Secondary outcomes (8)
Desire domain in the Female Sexual Function Index
Change of the Desire domain in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Item 13 score in the Female Sexual Distress Scale-Revised
Change of Item 13 score in the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Satisfying sexual events
Change in the number of satisfying sexual events (SSEs) in proportion to the 28 day period after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The total score of the Female Sexual Function Index
Change of the total score of the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The total score of the Female Sexual Distress Scale-Revised
Change of total score of the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The sexual function according to the Female Sexual Function questionnaire
Change of the sexual function according to the Female Sexual Function questionnaire (FSF) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The 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 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of the follow-up.
Measured: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Number of adverse events
Frequency of adverse events reporting, including serious adverse events, in treatment groups.
Measured: 28 days (4 weeks) of treatment and 56 days (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 posted15 Mar 2017
- Study start14 Mar 2016
- Primary completion4 Apr 2017
- Study completion25 Jul 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 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 Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080298
- Sponsor's protocol ID
- BP101-SD01
- Status last verified
- Aug 2017
- First submitted
- 3 Mar 2017
- Last updated
- 18 Aug 2017
- 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 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2a Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
- ClinicalTrials.gov ID
- NCT03080298
- Acronym / sponsor ID
- BP101-SD01
- Conditions
- Hypoactive Sexual Desire Disorder (HSDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Ivix LLXIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 15 Mar 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.
This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.
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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged 21 or older, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3 (see Annex 7)).
- The level of follicle-stimulating hormone (FSH) is not more than 25 milli-International unit per ml (mIU/ml) according to the screening values.
- Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the hypoactive sexual desire disorder (HSDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
- Current HSDD episode lasting not less than 24 weeks.
- Patients with secondary female sexual arousal disorder (FSAD) and/or female orgasmic disorder (FOD) will be eligible only if the HSDD developed before the FSAD and/or FOD and the HSDD has a more significant impact on the patient's quality of life.
Key exclusion criteria (7 listed)
- Any prohibited treatments.
- Other mental disorders or psychiatric diseases.
- 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.
- Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc).
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 |
|---|---|---|
| BP101 | Drug | Treatment with BP101 |
| Placebo | Drug | Treatment with placebo |
Primary outcome
Desire domain score in the Female Sexual Function Index
Time frame: 28 days (4 weeks) of treatment
Change in the Desire domain score in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of treatment compared with the baseline.
Item 13 score in the Female Sexual Distress Scale-Revised
Time frame: 28 days (4 weeks) of treatment
Change of Item 13 score in the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) of treatment compared with the baseline.
8 secondary outcomes
Desire domain in the Female Sexual Function Index
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Item 13 score in the Female Sexual Distress Scale-Revised
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Satisfying sexual events
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The total score of the Female Sexual Function Index
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The total score of the Female Sexual Distress Scale-Revised
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The sexual function according to the Female Sexual Function questionnaire
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Number of adverse events
Time frame: 28 days (4 weeks) of treatment and 56 days (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 18 Aug 2017.
- 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 G Nemenov, MD study director
IVIX Ltd.
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 BP101 in people with Hypoactive Sexual Desire Disorder (HSDD), run by Ivix LLX at 12 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 10 inclusion and 7 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 18 Aug 2017. 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 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 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?
Desire domain score in the Female Sexual Function Index (time frame: 28 days (4 weeks) of treatment). The study lists 2 primary outcomes in all. 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 18 Aug 2017.