CLINICAL TRIAL

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.

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.

 Gynecology, Shamsah Amersi, M.D., has gained acclaim for her renowned expertise in female sexuality, libido, and the effects of childbirth on pelvic prolapse. She specializes in both surgical and non-surgical treatments for vaginal relaxation and serves as the consulting physician for pk24.

In my view as a women's medical doctor, sexual satisfaction and wellness are critical to the overall health of a woman. In my clinical experience, I diagnose and treat a vast majority of women who are suffering from vaginal laxity. As a result, they are suffering from a significant decrease in overall sexual satisfaction that impacts their life, self-esteem, and their relationships. 

Vaginal Laxity is a condition where the connective tissues that support the vagina have become loose due to sexual intercourse, childbirth, or old age. A loose vagina is often experienced by women going through menopause or those who have recently been through childbirth. Your vagina is also likely to loosen if you have sex too often. Women also experience heightened sexual sensations with a tightened vagina, whereas a loose vagina leads to delayed orgasms because of reduced friction between the penis and vagina. Some women with a loose vagina have lesser sexual satisfaction, while others are even unable to have orgasms. 

FACTORS LEADING TO VAGINAL LAXITY AND LOSS OF PELVIC FLOOR  MUSCLES: 

- menopause 

- pregnancy 

- childbirth (especially vaginal) 

- aging 

- overweight 

- chronic constipation or coughing 

Because there is no such thing as a standard or ideal vagina size, it is difficult to estimate whether you have a loose vagina. If your sexual partner doesn’t have any complaints, the following indicators will tell you if you need to tighten your vagina:

1. You only get stimulated by inserting larger objects into it.

2. You find it tough to grip your vagina with your index finger. 

3. Your vagina is unable to close completely even when you are not in a state of arousal.

4. It is possible to insert more than three fingers into your vagina easily.

5. Orgasm is harder to achieve than before.

6. You find it harder to satisfy your partner. 

A loose vagina is known to lead to conditions such as lesser sensitivity, diminished sexual pleasure as well as incontinence. Another condition associated with vaginal looseness is that of female urinary incontinence. Vaginal looseness contributes to urinary incontinence because the loose nerves and muscles of the vagina are unable to hold urine or control its release. 

VAGINAL TIGHTENING SURGERY: 

Cosmetic vaginoplasty is a surgical procedure being marketed by some doctors as a  way to tighten and tone a woman's vaginal muscles after childbirth-supposedly to improve the appearance of the vagina and to increase sexual enjoyment. However, the American College of Obstetricians and Gynecologists warns against cosmetic vaginoplasty and other so-called vaginal rejuvenation procedures. The benefits of genital cosmetic surgery are unclear and research on the safety and effectiveness of cosmetic vaginoplasty is limited.  

Furthermore, the risks of surgical treatment for the purpose of vaginal tightening are potentially serious including: 

 bleeding 

 infection 

 scarring 

 painful intercourse 

 poor cosmetic irreversible outcome  

 incontinence  

 loss of sexual sensation  

 anesthesia risks 

 The vagina will lose its newly-acquired tightness if you give birth again 

 blood clots 

prolonged recovery time including abstinence from intercourse, exercise, strenuous activity for approximately six weeks, and large financial expenses - insurances do not cover cosmetic genital surgery and the average cost is $5000-$10000, if not more depending on which city and doctor you choose. 

It is a short-term and expensive option for alleviating vaginal laxity. Surgery is the absolute last resort in my medical opinion for all medical conditions, and should only be explored once you have exhausted more conservative, natural, and safer routes of treatment.  

CONSERVATIVE, SAFE, AND EFFECTIVE FIRST-LINE TREATMENTS FOR  VAGINAL RELAXATION: 

In my clinical practice, I have been very pleased with the effectiveness of combining  Kegel exercises and vaginal creams to significantly improve my patient's sexual satisfaction and self-esteem. This in turn translates to a satisfied sexual partner, which is always an added bonus. Whether my patient is in her 3rd decade of life or 7th decade of life it is imperative that her sexual concerns are addressed with solutions that are safe, affordable, and most of all effective. 

1. KEGELS: 

Kegel away, ladies!  

Kegel exercises strengthen the pelvic floor muscles, which support the uterus, bladder, and bowel. You can do Kegel exercises discreetly just about anytime, whether you're driving, sitting at your desk, or relaxing on the couch. You can even do them during intercourse to enhance the friction between the vagina and penis.  

How to do Kegel exercises 

It takes diligence to identify your pelvic floor muscles and learn how to contract and relax them. Here are some pointers: 

1 Find the right muscles. Insert a finger inside your vagina and try to squeeze the surrounding muscles. You should feel your vagina tighten and your pelvic floor move upward. Then relax your muscles and feel your pelvic floor return to the starting position. You can also try to stop the flow of urine when you urinate. If you succeed, you've got the basic move.  

2 Perfect your technique. Once you've identified your pelvic floor muscles, empty your bladder and sit or lie down. Contract your pelvic floor muscles, hold the contraction for five seconds, then relax for five seconds. Try it four or five times in a row. Work up to keeping the muscles contracted for 10 seconds at a time,  relaxing for 10 seconds between contractions. 

1. VAGINAL TIGHTENING CREAMS (pk24) 

As a physician and as a woman, I find myself inundated with claims from various products reporting to transform us back into the way we looked and felt pre-life/baby/ childbirth/menopause. It can be overwhelming for my patients to navigate through the endless products that one is best suited to their needs. It is incumbent on a patient to do their diligence.

For me, what I look at first when a product is presented to me is:  WHAT IS THE CLINICAL TRIAL AND MEDICAL RESEARCH ON THE PRODUCT?  Without any medical data to support the claims of a product, I am unable to recommend a product to my patients. When pk24 was presented to me with the clinical responses from actual clinical trials I was extremely impressed. The ingredients are primarily natural, and safe, with no side effects, noted including infections. 

Many gynecologists warn if women are already susceptible to recurring yeast infections, they should steer clear of personal lubricants containing glycerin. Since it is processed exactly like sugar in the body and applied directly to the vagina, it is assumed vaginal yeast benefits from its addition. However, the medical literature shows that using lubricants with glycerin is safe. KY Jelly, the No.1 brand in America, is full of glycerin. 

KY is also the lubricant used by the majority of obstetricians/gynecologists for all pelvic examinations on patients.  

The clinical medical trials revealed consistently that pk24 results in a heightened sense of orgasm, increased orgasm frequency, and an increased feeling of vaginal tightness. This results in a satisfying sexual experience and an overall sense of well-being. Best of all, it is affordable and you can order it without needing a prescription, but still feel safe that it is suggested in the medical community.

CLINICAL TRIAL

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. Trial posted below

 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, an innovative, non-surgical solution for internal vaginal tightening & enhancement. pk24 is designed to enhance the experience primarily for women and ultimately both partners. The effect created by pk24 is impressive, 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. 78% of subjects report increased satisfaction and frequency of arousal (excitement) during sexual activity or intercourse.

  6. 88% of subjects report an increase in natural lubrication during sexual activity or intercourse. No decrease was reported.

  7. 78% of subjects report an increase in the ability to maintain lubrication wetness until the completion of activity or intercourse.

 8. 89% of subjects report an increase in their ability to “climax”.

9. 88% of subjects report an increase in satisfaction with their ability to climax during intercourse and of these subjects, 78% reported an increased frequency of orgasm.

10. 100% of subjects report an increase in emotional closeness during sexual activity with their partner.

11. 78% of subjects report an increase in satisfaction level with their sexual relationship with their partner.

12. 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): a 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