Novel topical formulation applied to the nipple-areola complex improves female orgasm.

BACKGROUND: The nipple-areola complex (NAC) is an often overlooked but important erogenous zone in the female sexual response and sexual functional repertoire. Research suggests that nipple stimulation is significant to female sexual satisfaction in as many as 80% of women. Previously, we have reported that stimulation of the arrector pili muscle in the NAC increases nipple sensitivity and has a positive impact on female sexual function. AIMS: To study the effect of RJ-101 on female orgasm. METHODS: A randomized double-blinded placebo-controlled study of RJ101, a novel topical formulation that stimulates the arrector pili muscle of the NAC, in 59 women. Each subject completed a survey composed of Likert scale questions in order to identify changes in orgasm after topical application of RJ101 or placebo. RESULTS: We demonstrated a positive increase in the perceived intensity of orgasm and orgasmic satisfaction/pleasure in women using RJ101 vs those in the placebo group. After 4 weeks of treatment, 76% of the women in the RJ101 arm reported a positive improvement in satisfaction with orgasm versus 47% in the placebo cohort. The mean change in score for overall satisfaction with orgasm in the RJ101 group was statistically significant (P = .007) compared to placebo. CONCLUSION: The application of RJ101 to the NAC 30 minutes prior to sexual activity can improve orgasmic strength, pleasure, and satisfaction.

The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression.

OBJECTIVE: To evaluate the efficacy of rEEG(®)-guided pharmacotherapy for the treatment of depression in those circumstances where rEEG and STAR*D provided different recommendations. MATERIALS AND METHODS: This was a randomized, single-blind, parallel group, 12 center, US study of rEEG-guided pharmacotherapy vs. the most effective treatment regimens reported in the NIH sponsored STAR*D study. Relatively treatment-resistant subjects ≥18 years who failed one or more antidepressants were required to have a QIDS-16-SR score ≥13 and a MADRS score ≥26 at baseline. All subjects underwent a washout of all current medications (with some protocol-specified exceptions) for at least five half-lives before receiving a QEEG and rEEG report. Subjects randomized to rEEG were assigned a regimen based on the rEEG report. Control subjects who had failed only SSRI's in their current episode were randomized to receive venlafaxine XR. Control subjects who had failed antidepressants from ≥2 classes of antidepressants were randomized to receive a regimen from Steps 2-4 of the STAR*D study. Treatment lasted 12 weeks. The primary outcome measures were change from baseline for self-rated QIDS-SR16 and Q-LES-Q-SF. RESULTS: A total of 114 subjects were randomized and 89 subjects were evaluable. rEEG-guided pharmacotherapy exhibited significantly greater improvement for both primary endpoints, QIDS-SR16 (-6.8 vs. -4.5, p<0.0002) and Q-LES-Q-SF (18.0 vs. 8.9, p<0.0002) compared to control, respectively, as well as statistical superiority in 9 out of 12 secondary endpoints. CONCLUSIONS: These results warrant additional studies to determine the role of rEEG-guided psychopharmacology in the treatment of depression. If these results were confirmed, rEEG-guided pharmacotherapy would represent an easy, relatively inexpensive, predictive, objective office procedure that builds upon clinical judgment to guide antidepressant medication choice.