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CLINICAL TRIAL

Clinical Trials

pk24 was tested for safety and efficacy by the National Institute of Clinical Research in Los Angeles. NICR is a nationally respected research center that conducts trials for Upjohn, Pfizer, Lilly, and other large pharmaceutical companies.

Medical Expert

Dr. Shamsah Amersi advisor on pk24 as its medical consultant. She is a prominent OB/Gyn in Santa Monica and is affiliated with UCLA Medical Center. Her thriving practice includes multiple A-list celebrity patients.

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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

Skin Laxity and internal V relaxation can be both surprising and unwanted results of childbirth, aging, or muscular de-conditioning. The muscles become relaxed and have poor tone, strength, and a lack of control. The internal and external diameters of the increase. As a result, the gratifying sensual side of contact can be significantly diminished for both partners.

pk24 is the most innovative, non-surgical solution for internal V tightening & enhancement. pk24 is designed to enhance the experience primarily for women and ultimately both partners. The effect created by pk24 is highly effective and simple to use.

Study Objectives:

Evaluate the efficacy and safety of pk24 for women compared to placebo in women in conjunction with intimate activities. Focus to evaluate the feeling of increased tightened sensation, fullness, and reported 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 in infection related to pk24 use.

      1. 80% of subjects report an increase in feelings of sexual desire or interest.

      2. 78% of subjects report an increase in the level of sexual desire or interest.

      3. 89% of subjects reported increased arousal during sexual activity or intercourse.

      4. 78% of subjects report an increase in how confident they were about becoming sexually aroused during sexual activity or intercourse.

      5. 68% of subjects report increased satisfaction and frequency of arousal (excitement) during sexual activity or intercourse.

      6. 80% of subjects report an increase in natural lubrication during sexual activity or intercourse. No decrease was reported.

      7. 78% of subjects report a decrease in difficulty becoming lubricated during sexual activity or intercourse.

      8. 78% of subjects report an increase in the ability to maintain lubrication wetness until the completion of activity or intercourse.

     9. 86% of subjects report an increase in ability to “climax”.

    10. 78% of subjects report an increase in satisfaction with their ability to climax during intercourse and of these subjects, 45% reported an increased frequency of orgasm.

    11. 100% of subjects report an increase in emotional closeness during sexual activity with their partner.

    12. 78% of subjects report an increase in satisfaction level with their sexual relationship with their partner.

    13. 100% of subjects report a decrease in discomfort or pain during vaginal penetration.

    References:

    Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281:537-544.

    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.

    Clayton AH, McGarvey EL, Clavet GJ. The changes in sexual functioning questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol Bull. 1997;33:731-745.

    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

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