At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC (”Plethora” AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE). Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo. Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.
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The study, conducted by Aletha Akers, M.D., M.P.H., assistant professor of gynecology and reproductive sciences at the University of Pittsburgh School of Medicine, and colleagues, further links girls at weight extremes with an increased risk for engaging in sexual risk-taking behaviors.
“This study will contribute to sexual health education prevention efforts, which can be tailored to address how cultural norms regarding body size may influence adolescent sexual decision making. Knowing how a girl perceives her weight may be just as important as knowing her actual weight,” noted Dr. Akers.
The most commonly reported sexual problems in the area of consensual sexuality in women relate to sexual desire and interest, pleasure and satisfaction, and for most women these are part of the overall sexual experience, and are inextricably related. In contrast to studies of interventions for male erectile dysfunction, benefit of treatment in women with sexual dysfunction cannot be measured simply by the frequency of sexual events, as women frequently continue to be sexually active despite a high level of sexual dissatisfaction. Thus the frequency of self-reported satisfactory sexual events has been used as the primary outcome in recent studies.
“So if 12 years was the average age here, that meant that some kids were starting at 10 or younger,” said Lohman, an Iowa State University associate professor of human development and family studies (HDFS). “A handful of kids reported having sex as early as 8 or 9. We know from our follow-up interviews that one boy who reported having sexual intercourse for the first time at age nine had fathered four children by the time he was 18.”
“Those people who say that kids don’t have sex at that young of age should think again,” she said. “Definitely the age is the most shocking thing about this study.”
This is just one of the key findings in a University of Michigan study of youth on what predicts age of sex partners. Jose Bauermeister, one of the authors, says age difference of sex partners is important, because a larger age difference is associated with riskier sexual behavior and STDs, including HIV.
The study found that a youth’s self esteem and alcohol use also play a role in the age difference between sex partners, says Bauermeister, an assistant research professor in the School of Public Health.
“These new findings represent an important step forward in HIV vaccine research,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.
“Over a period of 9 years, we studied 512 HIV positive repeat offender inmates from the San Francisco County jail system,” says Dr. Pant Pai. “Our results show that only 15% continuously took their ART between incarcerations or after their release.” According to the study, published in the journal PLoS ONE, these figures highlight a lack of effectiveness on the part of medical monitoring services for these people outside prison.
“Taking ART intermittently is a problem because it depletes the CD4 count – the immunizing cells that fight infection – and increases the probability of developing resistance to the virus,” says Dr. Pant Pai. “The risk for rapid disease progression becomes higher and presents a risk for public health transmission of HIV to their partners.” According to the study those on intermittent therapy were 1.5 times more likely to have higher virus load than those on continuous therapy; those who never received therapy were 3 times more likely to have a higher VL.
Eli Lilly and Company (NYSE: LLY) announced results from a double-blind, placebo-controlled study which showed that tadalafil 5 mg dose taken once daily was generally well-tolerated, improved erectile function for men with erectile dysfunction (ED) and reported improvement in the sexual quality of life scores for men and their female partners. The 12-week study monitored 342 men and their partners, using several scientific questionnaires to assess changes in erectile function and sexual quality of life before and after treatment with a tadalafil once daily dose. The study appears in the May issue of the peer-reviewed Journal of Sexual Medicine.
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VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction (ED).
VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.v Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS’ investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.
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A long-term study by researchers at UCLA’s Jonsson Comprehensive Cancer Center found that the three most common treatments for localized prostate cancer had significant impacts on patients’ quality of life, a finding that could help guide doctors and patients in making treatment decisions.
The four-year study, which followed 475 men treated for early stage prostate cancer, also resulted in the development of “probability plots,” gauges which can be used to predict when treatment side effects such as urinary incontinence, sexual dysfunction or bowel problems might return to normal, or whether the patient will ever fully recover. Such predictions could be used to determine whether further treatments or surgeries are needed to deal with adverse side effects, said Dr. John Gore, an urologist and the study’s first author.
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