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).
Completed
- Conditions
- 100147011004048010013356Hypoactive Sexual Desire Disorder and Anorgasmia
- Registration Number
- NL-OMON34282
- Lead Sponsor
- Trimel Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary end-point:<br /><br>a) To evaluate the PK profile of TBS-2 administered BID in patients with HSDD<br /><br>or ANOR.<br /><br><br /><br>The serum concentrations of total testosterone and dihydrotestosterone will be<br /><br>measured using validated LC/MS/MS. The following pharmacokinetic parameters<br /><br>will be determined for all subjects:<br /><br><br /><br><br /><br>- Cmin, Cmax, tmax, PTF and PTS will be determined, for each dosing interval<br /><br>- AUC0-*, and Cavg, will be calculated for each dosing interval.<br /><br>- The percentage of time within, below, and above the physiological reference<br /><br>range for serum testosterone and dihydrotestosterone.</p><br>
- Secondary Outcome Measures
Name Time Method