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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
研究者
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