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| ID | Type | Description | Link |
|---|---|---|---|
| KPSC IRB 6428 | Other Identifier | Kaiser Permanente Southern California Institutional Review Board |
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The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.
Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promescent Lidocaine Spray | Active Comparator | Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out |
|
| Placebo | Placebo Comparator | Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | During the Double-Blind Treatment Period, patients randomized to placebo will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg. During the Open-Label Treatment Period, the patient will receive four weeks of Promescent (active treatment) in one-week cycles: 30 mg, 50 mg, 70 mg, and patient's self-selected dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Intravaginal Ejaculatory Latency Time (IELT) in seconds | The primary efficacy outcome is the proportion of subjects that achieve a mean IELT of greater than 90 seconds at Week 3, 7, and 11. | Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective distress | Week 3, 7, and 11 | |
| Perception of improvement in premature ejaculation | Week 3, 7, and 11 | |
| Perceived optimal dosage of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Y Rhee, MD, MBA | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Los Angeles | California | 90027 | United States | ||
| Kaiser Permanente |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Promescent Lidocaine Spray | Drug | During the Double-Blind Treatment Period, patients randomized to active treatment will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg, followed by four weeks of treatment during the Open-Label Treatment Period using patient's self-selected dose. |
|
| Week 3, 7, and 11 |
| Adverse events/reactions to treatments | Week 11 |
| San Diego |
| California |
| 92154 |
| United States |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |