NCT03080298已完成2 期
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
Ivix LLX12 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2016年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 12
- 主要终点
- Desire domain score in the Female Sexual Function Index
研究概览
简要总结
This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
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
Desire domain score in the Female Sexual Function Index
时间窗: 28 days (4 weeks) of treatment
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
时间窗: 28 days (4 weeks) of treatment
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.
次要结局
- 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)
- Item 13 score in the Female Sexual Distress Scale-Revised(28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up)
- The sexual function according to the Female Sexual Function questionnaire(28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up)
- Desire domain in the Female Sexual Function Index(28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up)
- Number of adverse events(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)
- The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement(28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up)
研究者
研究点 (12)
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