Clinical trial NCT03463707: BP101 for Adults With Female Sexual Dysfunction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Female Sexual Dysfunction
Sexual Desire Disorder
Lead sponsor: Ivix LLX
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 205
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Satisfying sexual events
timeFrame: Baseline and 4 weeks of treatment
Secondary outcomes:
measure: Satisfying sexual events
timeFrame: Baseline and 4 and 8 weeks of follow-up
measure: Orgasms
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index total score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Desire domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Arousal domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Lubrication domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Orgasm domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Satisfaction domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Function Index Pain domain score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Distress Scale-Revised Total score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Female Sexual Distress Scale-Revised Item 13 score
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Sexual function according to the Female Sexual Function questionnaire
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement
timeFrame: Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
measure: Number of adverse events
timeFrame: During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up)
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Алтайский государственный медицинский университет
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Obstetrics, Gynecology and Perinatology
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky
city: Nizhniy Novgorod
country: Russian Federation
facility: Clinical Psychiatry Hospital №1
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital No. 2
city: Saint Petersburg
country: Russian Federation
facility: City psychiatric hospital №7 named after academician I.P. Pavlov
city: Saint Petersburg
country: Russian Federation
facility: Doctor SAN Ltd.
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Narcological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: OrKli Hospital LLC
city: Saint Petersburg
country: Russian Federation
facility: Research center Eco-Safety LLC
city: Samara
country: Russian Federation
facility: Samara Psychiatric Hospital
city: Saratovskaya
country: Russian Federation
facility: Engels Psycyatric hospital
city: Saratov
country: Russian Federation
facility: Regional Clinical Psychiatric Hospital of St. Sofia
city: Tomsk
country: Russian Federation
facility: Clinic "Hundred Years"
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Yaroslavl'
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatric Hospital
Study officials:
affiliation: Ivix LLX
name: Daniil G. Nemenov, MD
role: STUDY_DIRECTOR
References: