Clinical Trials

Shamsah Amersi, M.D., Medical Advisor

Shamsah Amersi, M.D. is a leading OB/GYN in the Los Angeles area, and consulting physician to pk24. A preeminent Board Certified physician in Obstetrics and Gynecology, Dr. Amersi received her undergraduate degree in psychobiology from UCLA, where she graduated summa cum laude, with Phi Beta Kappa membership. At UC San Francisco medical school, Dr. Amersi graduated with top honors, and was recognized as a distinguished member of alpha omega alpha, an honor society for the top 5% of all medical doctors.

Dr. Amersi has received numerous professional and academic awards, including the University of California Distinguished Scholar Award for four consecutive years, an endowed merit scholarship, and the UCLA Alumni Association Achievement Award for four consecutive years. Her special interest in female sexuality, libido and the effects of childbirth on pelvic prolapse has led to Dr. Amersi's renowned expertise in these fields. She performs both surgical and nonsurgical treatments for pelvic prolapse and vaginal relaxation.
Through her private practice in Santa Monica, CA, Dr. Amersi is the personal physician to Hollywood A-list celebrities.

 Clinical Trials

Vaginal relaxation can be an unwanted result of childbirth, aging or muscular de-conditioning. The muscles become relaxed and have poor tone, strength, and lack control. The internal and external diameters of the vagina increase. As a result, the sensual side of sexual gratification can become greatly diminished for both partners.

PK24 is the newest and most innovative non-surgical solution for vaginal tightening. PK24 is designed to renew, restore and rejuvenate the interior walls of the vagina for up to 24 hours, thus restoring the physiological aspects of sexual gratification for both partners.

Study Objectives:

Evaluate the efficacy and safety of PK24 for women compared to placebo in women in conjunction with sexual activities. Focus to evaluate feeling of increased fullness, sensation and sexual pleasure for both partners.

Testing:

Prospective, Randomized, Double-Blind, Placebo controlled Pilot Trial of the efficacy and safety of PK24® for women with vaginal wall relaxation. Two-thirds of women subjects received PK24 while the remaining one-third received a placebo. Vaginal smears did not show any increase of infection related to PK24 use.

      1.  80% of subjects report an increase in (no decrease experienced) in feelings of sexual desire or interest.

      2.  78% of subjects report an increase in (no decrease experienced) in level (degree) of sexual desire or interest.

      3.  89% of subjects report increase (no decrease experienced) in feeling sexually aroused during sexual activity or intercourse.

      4.  89% of subjects report increased (no decrease experienced) in level of sexual arousal during sexual activity or intercourse.

      5.  78% of subjects report increased (no decrease experienced) in how confident they were about becoming sexually aroused during sexual activity or intercourse.

      6.  68% of subjects report increased (no decrease experienced) in satisfaction and frequency of arousal (excitement) during sexual activity or intercourse.

      7.  80% of subjects report increase (no decrease experienced) in increased lubrication during sexual activity or intercourse.

      8.  78% of subjects report decrease (no increased difficulty experienced) in difficulty becoming lubricated during sexual activity or intercourse.

      9.  78 % of subjects report increase (no decrease experienced) in ability to maintain lubrication wetness until completion of sexual activity or intercourse.

    10. 78% of subjects report decrease (no increase experienced) in difficulty maintaining lubrication “wetness” until completion of sexual activity or intercourse.

    11. a) 100% of subjects report increased frequency of orgasm “climax” or (no decrease experienced) in frequency of orgasm. b)  45% report increase in frequency of orgasm using PK24 c)  0% report decrease in frequency of orgasm

    12. a) 86% of subjects report no increase in difficulty reaching orgasm, “climax” (no difficulty experienced). b) 45 % report increase in ability to achieve orgasm (climax).

    13. 78% of subjects report increase (no decrease experienced) in satisfaction with their ability to reach orgasm (climax) during sexual activity or intercourse.

    14. a) 100% subjects report increase (no decrease experienced) in emotional closeness during sexual activity with their partner. b) 45 % report increase in emotional closeness during sexual activity with their partner.

    15. 78% of subjects report increase (no decrease experienced) in satisfaction level with their sexual relationship with their partner.

    16. 100% of subjects report decrease (no increase experienced) in discomfort or pain during vaginal penetration.

    17. 89% of subjects report decrease (no increase experienced) with discomfort or pain during vaginal penetration.

    18. 78 % of subjects report a decrease (no increase experienced) in discomfort or pain following vaginal penetration.

      References

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      Bancroft J. Sexual well being of women in heterosexual relationships: a national survey. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 17.

      Cain V, Johannes C, Mohr B, et al. Sexual practices among ethnically diverse midlife women. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 45

      Meston C. Instruments designed to assess female sexual function. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 184.

      Derogatis L. The Derogatis interview for sexual functioning (DISF/DISF-SR): introductory report. J Sex Marital Ther. 1997;23:291-304.

      Rust J, Golombok S. The Golombok-Rust Inventory of Sexual Satisfaction. Odessa, Fla: Psychological Assessment Resources, Inc.; 1986.

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      Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI):

      a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191-208.

      Derogatis LR. Female sexual distress scale (FSDS): preliminary report. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; pp 175-180.

      Osborn M, Hawton K, Gath D. Sexual dysfunction among middle aged women in the community. BMJ. 1988;296:959-962.

      National Institute of Clinical Research, 1127 Wilshire Blvd, Suite 809, Los Angeles, CA 90017X