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

NCT03080298 | Completed Phase 2

• 1 other identifier: BP101-SD01
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 12

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.

Conditions

Hypoactive Sexual Desire Disorder (HSDD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Desire domain in the Female Sexual Function Index

  28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

• Item 13 score in the Female Sexual Distress Scale-Revised

  28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

• Satisfying sexual events

  28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

• The total score of the Female Sexual Function Index

  28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

• The total score of the Female Sexual Distress Scale-Revised

  28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up

Study Arms (2)

Treatment with BP101

EXPERIMENTAL

Drug: BP101

Treatment with placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BP101 DRUG

Treatment with BP101

Placebo DRUG

Treatment with placebo

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ivix LLX: lead

Study Sites (12)

V.M. Bekhterev Republic Clinical Psychiatric Hospital

Kazan', Russia

Location

"People's Friendship University of Russia"

Moscow, Russia

Location

Mental Health Research Center

Moscow, Russia

Location

N.A. Alexeev Moscow Psychiatric Clinical Hospital #1

Moscow, Russia

Location

Clinical Psychiatry Hospital №1

Nizhny Novgorod, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital #1

Orenburg, Russia

Location

OrKli Hospital LLC

Saint Petersburg, Russia

Location

Regional Clinical Psychiatric Hospital of St. Sofia

Saratov, Russia

Location

Engels Psycyatric hospital

Saratov Oblast, Russia

Location

Clinic "Hundred Years"

Tomsk, Russia

Location

Yaroslavl Regional Clinical Psychiatric Hospital

Yaroslavl, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Daniil G Nemenov, MD

  IVIX Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 15, 2017
• Study Start: March 14, 2016
• Primary Completion: April 4, 2017
• Study Completion: July 25, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)