BP101 for Adults With Female Sexual Dysfunction
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| ClinicalTrials.gov Identifier: NCT03463707 |
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Recruitment Status :
Completed
First Posted : March 13, 2018
Last Update Posted : February 11, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypoactive Sexual Desire Disorder Female Sexual Dysfunction Sexual Desire Disorder | Drug: BP101 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 205 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 5, 2018 |
| Actual Primary Completion Date : | November 26, 2018 |
| Actual Study Completion Date : | January 23, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment with BP101 |
Drug: BP101
Investigational product BP101, nasal spray |
| Placebo Comparator: Treatment with placebo |
Drug: Placebo
Placebo to Investigational product BP101, nasal spray |
- 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.
- Satisfying sexual events [ Time Frame: Baseline and 4 and 8 weeks of follow-up ]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.
- Orgasms [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]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.
- Female Sexual Function Index total score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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).
- Female Sexual Function Index Desire domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Function Index Arousal domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Function Index Lubrication domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Function Index Orgasm domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Function Index Satisfaction domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Function Index Pain domain score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Female Sexual Distress Scale-Revised Total score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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).
- Female Sexual Distress Scale-Revised Item 13 score [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- Sexual function according to the Female Sexual Function questionnaire [ Time Frame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up ]
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.
- 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 ]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.
- Number of adverse events [ Time Frame: During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up) ]Frequency of adverse events reporting, including serious adverse events, in treatment groups.
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| Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Women aged from 21 to 50 years old |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463707
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| Study Director: | Daniil G. Nemenov, MD | Ivix LLX |
| Responsible Party: | Ivix LLX |
| ClinicalTrials.gov Identifier: | NCT03463707 |
| Other Study ID Numbers: |
BP101-SD02-RUS |
| First Posted: | March 13, 2018 Key Record Dates |
| Last Update Posted: | February 11, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Disease Sexual Dysfunctions, Psychological Pathologic Processes Mental Disorders |