NCT03463707已完成3 期
Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
Ivix LLX20 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2018年3月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 20
- 主要终点
- Satisfying sexual events
研究概览
简要总结
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 disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment with BP101
Experimental
干预措施: BP101 (Drug)
Treatment with placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Satisfying sexual events
时间窗: Baseline and 4 weeks of treatment
Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 weeks of treatment, compared with the baseline.
次要结局
- Satisfying sexual events(Baseline and 4 and 8 weeks of follow-up)
- Orgasms(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Desire domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Lubrication domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Orgasm domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Satisfaction domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index total score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Distress Scale-Revised Item 13 score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Sexual function according to the Female Sexual Function questionnaire(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Arousal domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Function Index Pain domain score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Female Sexual Distress Scale-Revised Total score(Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up)
- Number of adverse events(During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up))
研究者
研究点 (20)
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