NL-OMON34282
已完成
不适用
Two-Center, In-Patient, Randomized, Placebo and Active Comparator Evaluation of the Pharmacokinetics (PK) and Safety, Along with Initial Pharmacodynamic (PD) Efficacy of Three Dose Levels of TBS-2 Intranasal Gel Applied Twice-Daily (BID) for up to Three Days in Female Patients with Hypoactive Sexual Desire Disorder (HSDD) or Anorgasmia (ANOR). - Eval. PK /Safety of TBS-2 Intranasal in Fem. Pat. with HSDD/ANOR
Trimel Biopharma SR0 个研究点目标入组 48 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hypoactive Sexual Desire Disorder and Anorgasmia
- 发起方
- Trimel Biopharma SR
- 入组人数
- 48
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Females up to 65 years
- •HSDD with personal distress
- •BMI equal to or less than 35
- •Women must have a score of \>11 on the FSDS\-R
排除标准
- •History of any clinically relevant other psychiatric disorders that could impact sexual function
- •History of Major Depressive Disorder within 6 months prior to study
- •Patients who meet DSM\-IV criteria for Sexual Aversion Disorder, Substance\-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
- •Patients with pelvic inflammatory disease, urinary tract or vaginal infection
结局指标
主要结局
未指定
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