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

Primary Purpose

Hypoactive Sexual Desire Disorder (HSDD)

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

BP101

Placebo

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder (HSDD)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with BP101

Treatment with placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Number of adverse events

Frequency of adverse events reporting, including serious adverse events, in treatment groups.

Full Information

NCT ID

NCT03080298

First Posted

March 3, 2017

Last Updated

August 15, 2017

Sponsor

Ivix LLX

1. Study Identification

Unique Protocol Identification Number

NCT03080298

Brief Title

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

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 14, 2016 (Actual)

Primary Completion Date

April 4, 2017 (Actual)

Study Completion Date

July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ivix LLX

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoactive Sexual Desire Disorder (HSDD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with BP101

Arm Type

Experimental

Arm Title

Treatment with placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BP101

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Desire domain score in the Female Sexual Function Index

Description

Change in the Desire domain score in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of treatment compared with the baseline.

Time Frame

28 days (4 weeks) of treatment

Title

Item 13 score in the Female Sexual Distress Scale-Revised

Description

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.

Time Frame

28 days (4 weeks) of treatment

Secondary Outcome Measure Information:

Title

Desire domain in the Female Sexual Function Index

Description

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.

Time Frame