introduction
Female sexual dysfunction is a significant age-related, progressive and highly prevalent problem that affects a substantial number of women in the United States.

It has been estimated that up to 76% of women, depending upon their age, have complaints of sexual dysfunction, including decreased libido, vaginal dryness, pain with intercourse, decreased genital sensation and difficulty or inability to achieve orgasm. Female sexual dysfunction is a significant problem that affects the quality of life of many women.

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. Under these circumstances, the vagina is no longer at its optimum physiological state. As a result, the sensual side of sexual gratification can become greatly diminished for both partners.

The female sexual response cycle is initiated by neurotransmitter-mediated vascular and nonvascular smooth muscle relaxation resulting in increased pelvic blood flow, vaginal lubrication, and clitoral and labial engorgement. These mechanisms are mediated by a combination of neuromuscular and vaso-congestive events. Physiological impairments that interfere with the normal female sexual response bring about complaints associated with diminished sexual arousal, libido, vaginal lubrication, genital sensation, and ability to achieve orgasm. Clinical symptoms may include delayed vaginal engorgement, diminished vaginal lubrication, pain or discomfort with intercourse, diminished vaginal sensation, diminished vaginal orgasm, diminished clitoral sensation or diminished clitoral orgasm.

Pelvic floor therapy with micro-stimulation of the vaginal musculature is used to promote perineal muscle strength.  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 increasing and restoring the physiological aspects of sexual gratification for both partners.

The ingredients in PK24 plump and tighten the interior walls of the vagina. PK24 increases fullness, sensation and sexual pleasure for both partners.

PK24 has been on the consumer market with no known reported side effects.

study objectives
The objective of this study: to evaluate the efficacy and safety of Pk24 for Women compared to placebo in women with vaginal wall relaxation in conjunction with sexual activities.

No side effects reported and no adverse events reported related to the medication.

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.
19. 89% of subjects report no increase or change in level, degree of discomfort or pain during or following vaginal penetration (no increased discomfort experienced).

testing
Prospective, Randomized, Double-Blind, Placebo controlled Pilot Trial of the efficacy and safety of PK24® for women with vaginal wall relaxation.

conclusion
Results have shown that the use of PK24 was safe.  There were no reported side effects related to the medication during the study period.

Vaginal smears did not show any increase of infection related to PK24 use.

references
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