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

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 - Evaluation of TBS-2 in females with anorgasmia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36429

Enrollment

Registered

2010-12-21

Start date

2011-02-28

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorgasmia and inability to achieve orgasm

Interventions

Subjects receive one dose (1.2 mg) of TBS-2 at visit 3

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Females aged 18 - 50 years Anorgasmia Premenopausal BMI equal or less than 35

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary end-point: - To evaluate the effect of a single dose of TBS-2 (1.2 mg) on the occurrence of orgasm at 0.5, 2.0, 4.0 and 8.0 hours post-dose in females suffering from primary or secondary anorgasmia . The study will evaluate the occurrence of orgasm following vibrotactile stimulation and visual sexual stimulation (VTS/VSS). The occurrence of orgasm will be evaluated based on subject self-report. The subject is required to press a button to indicate orgasm start.	—

Measure

Time frame

Primary end-point: - To evaluate the effect of a single dose of TBS-2 (1.2 mg) on the occurrence of orgasm at 0.5, 2.0, 4.0 and 8.0 hours post-dose in females suffering from primary or secondary anorgasmia . The study will evaluate the occurrence of orgasm following vibrotactile stimulation and visual sexual stimulation (VTS/VSS). The occurrence of orgasm will be evaluated based on subject self-report. The subject is required to press a button to indicate orgasm start.

—

Secondary

Measure	Time frame
Secondary end-points: a) To evaluate the effect of a single dose of TBS-2 (1.2 mg) on time to orgasm (TTO) at 0.5, 2.0, 4.0 and 8.0 hours post-dose in female subjects with primary or secondary anorgasmia . TTO will be recorded as the time from onset of VTS/VSS stimulation until the start of orgasm at which time the subject will press a button so that TTO will be automatically recorded by the computer program. b) To evaluate the effect of a single dose of TBS-2 (1.2 mg) on quality of orgasm at 0.5, 2.0, 4.0 and 8.0 hours post-dose in female subjects with primary or secondary anorgasmia . Quality of orgasm will be assessed by Quality of Orgasm Questionnaire c) To assess the safety of TBS-2. The following close-out parameters will be compared to the baseline results: - Vital Signs: blood pressure, body temperature, respiratory rate, heart rate. - Hematology: CBC, hemoglobin and hematocrit values. - Clinical Chemistry Profile - Na/K, glucose, urea, creatinine, calcium, phosphate, uric acid, total bilirubin, albumin, AST, ALT, ALP, GGT, CK, LDL, HDL, triglycerides. - Thyroid panel - TSH, total and free tri-iodothyronine, total and free thyroxine. - Hormone Profile - Estradiol, Free Testosterone, Free Testosterone (percent), Follicle Stimulating Hormone, Luteinizing Hormone, Prolactin, Progesterone, Sex Hormone Binding Globulin, Total Testosterone, Dehydroepiandrosterone Sulfate - Urinalysis - Urine specific gravity, glucose, protein, ketone, pH, bilirubin, urobilinogen, nitrite, erythrocytes and leukocytes. - Adverse events	—

Measure

Time frame

Secondary end-points: a) To evaluate the effect of a single dose of TBS-2 (1.2 mg) on time to orgasm (TTO) at 0.5, 2.0, 4.0 and 8.0 hours post-dose in female subjects with primary or secondary anorgasmia . TTO will be recorded as the time from onset of VTS/VSS stimulation until the start of orgasm at which time the subject will press a button so that TTO will be automatically recorded by the computer program. b) To evaluate the effect of a single dose of TBS-2 (1.2 mg) on quality of orgasm at 0.5, 2.0, 4.0 and 8.0 hours post-dose in female subjects with primary or secondary anorgasmia . Quality of orgasm will be assessed by Quality of Orgasm Questionnaire c) To assess the safety of TBS-2. The following close-out parameters will be compared to the baseline results: - Vital Signs: blood pressure, body temperature, respiratory rate, heart rate. - Hematology: CBC, hemoglobin and hematocrit values. - Clinical Chemistry Profile - Na/K, glucose, urea, creatinine, calcium, phosphate, uric acid, total bilirubin, albumin, AST, ALT, ALP, GGT, CK, LDL, HDL, triglycerides. - Thyroid panel - TSH, total and free tri-iodothyronine, total and free thyroxine. - Hormone Profile - Estradiol, Free Testosterone, Free Testosterone (percent), Follicle Stimulating Hormone, Luteinizing Hormone, Prolactin, Progesterone, Sex Hormone Binding Globulin, Total Testosterone, Dehydroepiandrosterone Sulfate - Urinalysis - Urine specific gravity, glucose, protein, ketone, pH, bilirubin, urobilinogen, nitrite, erythrocytes and leukocytes. - Adverse events

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)