Status:
COMPLETED
BP101 for Adults With Female Sexual Dysfunction
Lead Sponsor:
Ivix LLX
Conditions:
Hypoactive Sexual Desire Disorder
Female Sexual Dysfunction
Eligibility:
FEMALE
21-50 years
Phase:
PHASE3
Brief Summary
This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorde...
Eligibility Criteria
Inclusion
- Women aged from 21 to 50 years old, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3).
- Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the diagnosis of acquired generalized hypoactive sexual desire disorder (HSDD) according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
- Current HSDD episode lasting not less than 24 weeks.
- 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
- Any prohibited treatments.
- Other mental disorders or psychiatric diseases.
- Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong.
- 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, precluding normal sexual activity.
- Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc), resulting in pain/dyspareunia, and/or precluding sexual contacts, and/or requires hormonal replacement treatment, and/or lead to the loss of sensibility while sexual contact.
- 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.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2019
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03463707
Start Date
March 5 2018
End Date
January 23 2019
Last Update
February 11 2020
Active Locations (20)
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1
Алтайский государственный медицинский университет
Barnaul, Russia
2
Kazan State Medical University
Kazan', Russia
3
Kuban State Medical University
Krasnodar, Russia
4
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russia