Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

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.

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder (HSDD)
• Intervention / Treatment: Drug: Placebo; Drug: BP101

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation
    • Sverdlovsk Regional Clinical Psychiatric Hospital
  • Kazan', Russian Federation
    • V.M. Bekhterev Republic Clinical Psychiatric Hospital
  • Moscow, Russian Federation
    • Mental Health Research Center
  • Moscow, Russian Federation
    • N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
  • Moscow, Russian Federation
    • "People's Friendship University of Russia"
  • Nizhniy Novgorod, Russian Federation
    • Clinical Psychiatry Hospital №1
  • Orenburg, Russian Federation
    • Orenburg Regional Clinical Psychiatric Hospital #1
  • Saint Petersburg, Russian Federation
    • OrKli Hospital LLC
  • Saratov, Russian Federation
    • Regional Clinical Psychiatric Hospital of St. Sofia
  • Saratov Oblast, Russian Federation
    • Engels Psycyatric hospital
  • Tomsk, Russian Federation
    • Clinic "Hundred Years"
  • Yaroslavl', Russian Federation
    • Yaroslavl Regional Clinical Psychiatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BP101	Drug: BP101
Placebo Comparator: Treatment with placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	28 days (4 weeks) of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

Collaborators and Investigators

• Sponsor: Ivix LLX
• Investigators: Study Director: Daniil G Nemenov, MD, IVIX Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2016
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: BP101-SD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No