Single-Center, Randomized Single-Blind Placebo-Controlled Five-Arm Parallel Group Study to Assess Efficacy of a Single Dose of TBS-2 Intranasal Gel at Four Time Points Post-Dose using Vibrotactile Stimulation combined with Visual Sexual Stimulation in Female Subjects with Primary and Secondary Anorgasmia
Phase 2
- Conditions
- Anorgasmia and inability to achieve orgasm10040480
- Registration Number
- NL-OMON36429
- Lead Sponsor
- Trimel Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Females aged 18 - 50 years
Anorgasmia
Premenopausal
BMI equal or less than 35
Exclusion Criteria
History of any clinically relevant other psychiatric disorder that could impact sexual function
History of Major Depressive Disorder within six (6) months prior to study
Subjects who meet DSM-IV criteria (APA) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary end-point:<br /><br>- To evaluate the effect of a single dose of TBS-2 (1.2 mg) on the occurrence<br /><br>of orgasm at 0.5, 2.0, 4.0 and 8.0 hours post-dose in females suffering from<br /><br>primary or secondary anorgasmia .<br /><br><br /><br>The study will evaluate the occurrence of orgasm following vibrotactile<br /><br>stimulation and visual sexual stimulation (VTS/VSS). The occurrence of orgasm<br /><br>will be evaluated based on subject self-report. The subject is required to<br /><br>press a button to indicate orgasm start.</p><br>
- Secondary Outcome Measures
Name Time Method