Clinical trial NCT03080298: Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoactive Sexual Desire Disorder (HSDD)
Lead sponsor: Ivix LLX
Sponsor class: INDUSTRY
First posted: 2017-03-15
Enrollment: 119
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.
* 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.

Primary outcomes:
measure: Desire domain score in the Female Sexual Function Index
timeFrame: 28 days (4 weeks) of treatment
measure: Item 13 score in the Female Sexual Distress Scale-Revised
timeFrame: 28 days (4 weeks) of treatment
Secondary outcomes:
measure: Desire domain in the Female Sexual Function Index
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: Item 13 score in the Female Sexual Distress Scale-Revised
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: Satisfying sexual events
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: The total score of the Female Sexual Function Index
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: The total score of the Female Sexual Distress Scale-Revised
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: The sexual function according to the Female Sexual Function questionnaire
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
measure: Number of adverse events
timeFrame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Psychiatric Hospital
city: Kazan'
country: Russian Federation
facility: V.M. Bekhterev Republic Clinical Psychiatric Hospital
city: Moscow
country: Russian Federation
facility: "People's Friendship University of Russia"
city: Moscow
country: Russian Federation
facility: Mental Health Research Center
city: Moscow
country: Russian Federation
facility: N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
city: Nizhniy Novgorod
country: Russian Federation
facility: Clinical Psychiatry Hospital №1
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital #1
city: Saint Petersburg
country: Russian Federation
facility: OrKli Hospital LLC
city: Saratov Oblast
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: Yaroslavl'
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatric Hospital
Study officials:
affiliation: IVIX Ltd.
name: Daniil G Nemenov, MD
role: STUDY_DIRECTOR
References: