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

Hypoactive Sexual Desire Disorder (HSDD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080298
• Other study ID #: BP101-SD01
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2017
• Last updated: August 15, 2017
• Start date: March 14, 2016
• Est. completion date: July 25, 2017

Study information

• Verified date: August 2017
• Source: Ivix LLX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 25, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder (HSDD)
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• BP101

• Placebo

Locations

Country	Name	City	State
Russian Federation	Sverdlovsk Regional Clinical Psychiatric Hospital	Ekaterinburg
Russian Federation	V.M. Bekhterev Republic Clinical Psychiatric Hospital	Kazan'
Russian Federation	"People's Friendship University of Russia"	Moscow
Russian Federation	Mental Health Research Center	Moscow
Russian Federation	N.A. Alexeev Moscow Psychiatric Clinical Hospital #1	Moscow
Russian Federation	Clinical Psychiatry Hospital ?1	Nizhniy Novgorod
Russian Federation	Orenburg Regional Clinical Psychiatric Hospital #1	Orenburg
Russian Federation	OrKli Hospital LLC	Saint Petersburg
Russian Federation	Regional Clinical Psychiatric Hospital of St. Sofia	Saratov
Russian Federation	Engels Psycyatric hospital	Saratov Oblast
Russian Federation	Clinic "Hundred Years"	Tomsk
Russian Federation	Yaroslavl Regional Clinical Psychiatric Hospital	Yaroslavl'

Sponsors (1)

Lead Sponsor	Collaborator
Ivix LLX

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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