Claims
- 1. A method of testing and determining efficacy of a therapeutic agent to modulate sexual stimulation in a testing subject, the method comprising:
(a) stimulating control subjects in a physiological region that effects sexual response with an electroejaculation probe according to a predetermined stimulating protocol; (b) determining ejaculation events in the control subjects; (c) administering to testing subjects a candidate therapeutic agent for modulating sexual stimulation; (d) stimulating the testing subjects with the electroejaculation probe according to the protocol of step (a); and (e) determining the ejaculation events in testing subjects and comparing the results with the ejaculation events in the control subjects to determine the efficacy of the candidate therapeutic agent.
- 2. The method of claim 1, wherein the therapeutic agent to modulate sexual stimulation is for combating premature ejaculation.
- 3. The method of claim 2, wherein the therapeutic agent comprises a delta opioid receptor agonist.
- 4. The method of claim 3, wherein the delta opioid receptor agonist comprises a peptide compound.
- 5. The method of claim 3, wherein the delta opioid receptor agonist comprises a non-peptide compound.
- 6. The method of claim 3, wherein the therapeutic agent comprises a compound selected from the group consisting of: diarylmethylpiperazines, Deltorphin I, [D-Ala2]-Deltorphin II, DADLE, biphalin, DPDPE, and DSLET.
- 7. The method of claim 1, wherein the electroejaculation probe comprises an electric bipolar rectal probe.
- 8. The method of claim 7, wherein the electric bipolar rectal probe comprises an elongated body having a center lumen and formed of a non-conducting material, wherein the elongated body has a first and second end, an anode exteriorly located on the first end of the elongated body, and a cathode exteriorly located in spaced relationship to the anode at a sufficient distance to position the physiological region proximate to the electrodes for passage of stimulating current through the physiological region.
- 9. The method of claim 8, wherein both the anode and cathode comprise platinum as a material of construction.
- 10. The method of claim 1, wherein the predetermined stimulating protocol is conducted at an operating frequency within a range of from about 35 Hz to about 45 Hz.
- 11. The method of claim 2, wherein a reduction in the test ejaculation percentage relative to the control ejaculation percentage indicates an efficacious therapeutic agent for delaying ejaculation.
- 12. The method of claim 1, wherein the predetermined stimulating protocol comprises multiple operating cycles of alternating stimulation periods and rest periods, and wherein operating voltage of each operating cycle increases in comparison with that of an immediately preceding operating cycle.
- 13. The method of claim 12, wherein the operating voltage is within a range of from about 3 volts to about 8 volts.
- 14. The method of claim 12, wherein the predetermined stimulating protocol is conducted at an operating frequency of about 40 Hz, and comprising the steps of:
(a) conducting an initial operating cycle at an operating voltage of about 3 volts, wherein said first operating cycle comprises four stimulation periods and four rest periods, and wherein duration of each stimulation/rest period is about two seconds; and (b) conducting additional operating cycles, as specified in step (a), except at a different operating voltage, wherein the operating voltage of each additional operating cycle increases about 0.5 volt in comparison with that of an immediately preceding operating cycle, until ejaculation occurs or the operating voltage reaches about 8 volts.
- 15. A method of determining dose dependency of an ejaculation reduction effect of a therapeutic agent for combating premature ejaculation, comprising the steps of:
(a) stimulating control subjects in a physiological region that effects sexual response with an electroejaculation probe according to a predetermined stimulating protocol; (b) determining ejaculation events in the control subjects; (c) administering to testing subjects a candidate therapeutic agent for modulating sexual stimulation; (d) stimulating the testing subjects with the electroejaculation probe according to the protocol of step (a); and (e) determining the ejaculation events in testing subjects and comparing the results with the ejaculation events in the control subjects; (f) repeating steps (c)-(e) for multiple times, wherein at each time a different dose of the candidate therapeutic agent is administered to the subject, and an ejaculation percentage is calculated for each dose; (g) comparing the ejaculation percentages of different doses of the therapeutic agent with the control ejaculation percentage as well as with one another, to determine dose dependency of ejaculation reduction effect of the therapeutic agent.
- 16. The method of claim 15, wherein the therapeutic agent comprises a delta opioid receptor agonist.
- 17. The method of claim 16, wherein the delta opioid receptor agonist comprises a peptide compound.
- 18. The method of claim 16, wherein the delta opioid receptor agonist comprises a non-peptide compound.
- 19. The method of claim 16, wherein the therapeutic agent comprises a compound selected from the group consisting of: SNC-80, SNC-121, diarylmethylpiperazines, Deltorphin I, [D-Ala2]-Deltorphin II, biphalin, DPDPE, and DSLET.
- 20. The method of claim 15, wherein the electroejaculation probe comprises an electric bipolar rectal probe.
- 21. The method of claim 20, wherein the electric bipolar rectal probe comprises an elongated body having a center lumen and formed of a non-conducting material, wherein the elongated body has a first and second end, an anode exteriorly located on the first end of the elongated body, and a cathode exteriorly located in spaced relationship to the anode at a sufficient distance to position the physiological region proximate to the electrodes for passage of stimulating current through the physiological region.
- 22. The method of claim 15, wherein the predetermined stimulating protocol is conducted at an operating frequency within a range of from about 30 Hz to about 70 Hz.
- 23. The method of claim 15, wherein the predetermined stimulating protocol is conducted at an operating frequency within a range of from about 40 Hz to about 45 Hz.
- 24. The method of claim 15, wherein the predetermined stimulating protocol comprises multiple operating cycles of alternating stimulation periods and rest periods, and wherein operating voltage of each operating cycle increases in comparison with that of an immediately preceding operating cycle.
- 25. The method of claim 24, wherein the operating voltage is within a range of from about 3 volts to about 8 volts.
- 26. The method of claim 25, wherein the predetermined stimulating protocol is conducted at an operating frequency of about 40 Hz, and comprising the steps of:
(a) conducting an initial operating cycle at an operating voltage of about 3 volts, wherein said first operating cycle comprises four stimulation periods and four rest periods, and wherein duration of each stimulation/rest period is about two seconds; and (b) conducting additional operating cycles, as specified in step (a), except at a different operating voltage, wherein the operating voltage of each additional operating cycle increases about 0.5 volt in comparison with that of an immediately preceding operating cycle, until the operating voltage reaches about 8 volts.
- 27. A method for determining ejaculation-delaying effect of a premature ejaculation therapy in a subject, comprising the steps of:
(a) stimulating the subject to ejaculation with an electroejaculation probe according to a predetermined stimulating protocol; (b) establishing a baseline stimulating duration for inducing ejaculation in said subject, according to data collected in step (a); (c) thereafter subjecting the subject to said premature ejaculation therapy while the subject is free of stimulation with said electroejaculation probe; (d) while the subject is under the influence of said premature ejaculation therapy, stimulating the subject to ejaculation with said electroejaculation probe according to said predetermined stimulating protocol; (e) establishing a stimulating duration under treatment, according to data collected in step (d); comparing the stimulating duration under treatment of step (e) with the baseline stimulating duration of step (b), to determine the ejaculating-delaying effect of the premature ejaculation therapy.
- 28. A bipolar rectal probe for sexual stimulation of a male testing subject comprising:
an elongated body having a center lumen aligned with the longitudinal axis of the elongated body, the elongated body formed of a non-conductive material of sufficient dimensions for rectal insertion into the testing subject, the elongated body having a first and second end, the first end for rectal insertion into the testing subject and a second end proximate to a power source; an anode formed of a conductive material connected to the power source and extending from the second end to the first end of the elongated body through the center lumen and extending to and through an outer surface of the first end to provide an exterior anode around the circumference of the first end; a cathode formed of a conductive material connected to the power source and extending from the second end to a middle section of the elongated body through the center lumen and extending to and through an outer surface of the middle section of the elongated body to provide an exterior cathode anode around the circumference of the middle section, wherein the cathode is spaced from the anode at a sufficient distance to locate a sensitive stimulating region of the testing subject between the electrodes, thereby allowing stimulating current to travel between the electrodes and through the sensitive stimulating region.
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority from U.S. Provisional Patent Application No. 60/345,215 filed on Jan. 2, 2002.
Provisional Applications (1)
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Number |
Date |
Country |
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60345215 |
Jan 2002 |
US |