SUMMARY
OBJECTIVE:
To evaluate the efficacy and safety of Oh! for Women in an open-labeled pilot study in women with sexual dysfunction of broad-spectrum etiology with more than 3 months duration.
METHOD:
25 women were enrolled in a 12-week prospective, open-labeled, flexible-dose study. Each woman received 1 capsule of Oh! for Women in the morning every day and, as needed, took 1-2 capsules at night approximately 30 minutes to 3 hours before engaging in sexual activity. Efficacy was determined by the responses to question 3 (sexual desire), question 6 (sexual pain), question 9 (orgasm function) and question 13 (overall satisfaction of sex life) of the 14-item questionnaire. Other measures of efficacy and safety included the questions about the patient's medical history and questions about Oh! for Women.
RESULTS:
At the end of the study, there was a statistically significant improvement in 4 descriptive evaluations of the 14-item questionnaire. Oh! for Women significantly increased the patient's sexual activities (p<0.05). 68% of the patients reported an improvement in sexual arousal. No side effects were reported during this 12-week study.
CONCLUSIONS:
This study suggests that Oh! for Women is an effective, well-tolerated alternative treatment for women with sexual dysfunction.
(12/25) of the subjects only achieved orgasm a few times or never had an orgasm and 36% (9/25) of the subjects had very severe or severe pain during sexual activities. 80% (20/25) of the subjects were "dissatisfied" or "very dissatisfied" with their overall sex life. 36% (9/25) of the subjects had sexual concerns of a psychological nature and 40% (10/25) of the subjects had sexual concerns of a physical nature. The other subjects' situations were uncertain.
At the beginning of the study, each subject was given open-labeled Oh! for Women product and instructions on how to take Oh! for Women as well as recommendations on their overall lifestyle. Each subject took 1 capsule in the morning daily for 12 weeks and, as needed, took 1-2 capsules approximately 30 minutes to 2 hours before engaging in sexual activities.
Each subject finished and submitted Questionnaire 2 (SEXUAL FUNCTION ASSESSMENT IN WOMEN AFTER THE ACTUAL TRIAL OF HONEYMOON) (see attachment-2) separately at the end of 4 week, 8 week and 12 week intervals after taking Oh! for Women initially.
RESULTS:
The compliance of this study and the acceptance of Oh! for Women were satisfactory. 25 subjects completed the 12-week trial period. 22 subjects took Oh! for Women every morning for 12 weeks without interruption and also took 1-2 capsules before engaging in any type of sexual activity. 3 subjects (3/25) took Oh! for Women inconsecutively, 2 of them took Oh! for Women only before engaging in sexual activities and the other 1 subject took Oh! for Women before engaging in activities, but she also took 1 capsule in the morning intermittently. All 25 subjects reported no side effects during the 12-week study. The effects of Oh! for Women in the women's sexual activities and sex life were evaluated statistically and the results are shown on Table 1 to Table 4.
CONCLUSION:
This open-labeled study evaluated the effects of Oh! for Women on a woman's sexual function including sexual activities and sex life. The results showed a significant improvement on forgoing aspects. No significant side effects were reported during this 12-week study. This study indicated that Oh! for Women is an effective, well-tolerated alternative treatment for women with fe male sexual dysfunction
