Female Sexual Well-Being Scale: responsiveness to interventional product use by sexually functional women.

INTRODUCTION: Initial psychometric evaluation of the Female Sexual Well-Being Scale(TM) (FSWB Scale(TM)) demonstrated its validity for assessing sexual well-being in sexually functional US women. AIM: To evaluate the responsiveness of the FSWB Scale to interventional products in sexually functional women and to confirm its psychometric validity. METHODS: In a 5-week, randomized, multicenter study, the responsiveness of FSWB Scale scores to interventional products was evaluated in 326 sexually functional, heterosexual women randomized to: (i) no intervention; (ii) couple lubricants (1 lubricant for female and second lubricant for male partner); (iii) female arousal gel; or (iv) female lubricant. At baseline, participants were instructed to have >or=3 occurrences of vaginal intercourse over the next 4 weeks. Participants assigned to an intervention were instructed to use the product immediately before intercourse. Women completed the self-administered FSWB Scale at week 1 (screening), week 2 (baseline), and week 5 (study end). MAIN OUTCOME MEASURES: Changes from baseline in the FSWB Scale overall score and four domain scores were analyzed using analysis of covariance. Additional analyses were conducted to confirm psychometric validity. RESULTS: The mean change from baseline in the FSWB Scale overall score improved significantly among the four arms (treatment-effect P = 0.03). The within-treatment mean increase from baseline in the overall score was significant for each product arm (all P

Vaginal dryness: a comparison of prevalence and interventions in 11 countries.

INTRODUCTION: There is limited research comparing cross-cultural differences in women's experiences of vaginal dryness. AIM: To examine international differences in the prevalence of vaginal dryness, the degree to which it is experienced as problematic or bothersome, the use of lubricants to alleviate it, and women's discussion of this problem with physicians. MAIN OUTCOME MEASURES: Questionnaire measuring the level of vaginal dryness and degree to which it is perceived as bothersome. METHODS: The Global Survey of Sexual Attitudes and Practices was administered to 6,725 women from 11 countries: UK, Germany, Japan, Australia, Canada, Spain, Italy, Mexico, Argentina, Brazil and Thailand. RESULTS: Prevalence of self-reported vaginal dryness varied from a minimum of 5.8% in Italy to a maximum of 19.7% in Brazil. The proportion of women with self-reported vaginal dryness who found it very bothersome varied as well (e.g., 5.6% UK, 26.4% Germany). Pain during intercourse ranged from a reported low of 3.6% in Australia to 18.6% in Brazil. Older women (50-65 years) as compared with younger women (18-34 years) reported significantly more vaginal dryness in the UK, Australia, Canada, Italy, Spain, Argentina, and Thailand (P values <0.02). The majority of women under 50 attributed vaginal dryness to inadequate sexual arousal while women over 50 believed it was because of aging or menopause. Cross-culturally, women differed substantially in the likelihood of discussing their sexual life/concerns with a physician. CONCLUSION: Women from different countries differ substantially in their experiences, concerns, and reports of vaginal dryness/sexual pain, as well as their familiarity with personal lubricants as a treatment. Researchers should assess the prevalence and degree of the bother of vaginal dryness in order to make international comparisons of the burden of this condition.

Female sexual well-being scale (FSWB scale): development and psychometric validation in sexually functional women.

INTRODUCTION: No validated instrument exists for measuring female sexual well-being (FSWB) in women without medical/psychosocial conditions. AIMS: To develop and psychometrically validate a self-administered Female Sexual Well-Being Scale (FSWB Scale) for assessing sexual well-being in sexually functional women. METHODS: Important aspects of FSWB were identified via focus groups, debriefing interviews, and administration of an initial scale to 111 US women aged 21-72 years reporting normal sexual function (Female Sexual Function Index >26). Principal components analysis and psychometric validity testing of a FSWB Scale were conducted in a second study of 332 women. MAIN OUTCOME MEASURES: To develop a FSWB Scale, based on qualitative input from women reporting normal sexual function, and determine its factor structure and psychometric validity. RESULTS: Four aspects of FSWB were identified from the qualitative research. Women's preferred language to describe sexual well-being and preferred response formats were incorporated into the scale. A principle components analysis of quantitative study data from 332 women aged 21-72 years reporting normal sexual function identified 5 factors with eigenvalues >1: interpersonal domain (6 items), cognitive-emotional domain (5 items), physical arousal domain (3 items), orgasm-satisfaction domain (3 items), and external lubrication domain (2 items). The external lubrication domain did not demonstrate strong positive correlations with the other 4 domains, so it was not retained in the final scale. A high degree of internal consistency was demonstrated for the 4 domains (Cronbach's alpha values: 0.84-0.92). Test-retest reliability over a 2-week period was high (r > 0.80) or moderately high (r > 0.70) for the 4 domain scores. Correlation coefficients between FSWB Scale domain scores and standardized scale scores for female sexual function, depression, and social desirability demonstrated the construct validity of the FSWB Scale. CONCLUSION: A 17-item FSWB Scale was developed and psychometrically validated as a reliable, multidimensional, self-administered instrument for assessing sexual well-being in women of different ages.

A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis.

PURPOSE: These studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers. SUBJECTS AND METHODS: In vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes. RESULTS: The lip cream's in vitro water vapor transmission rate (84.1 g/(m2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)- and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDermFT) and pros-taglandin E2 release (EpiDermFT and EpiGingival™). The lip cream's in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (difference: -7.19 [95% CI: -11.41, -2.98]; P<0.01), increased corneometry (difference: 4.62 [95% CI: 1.05, 8.19]; P<0.05), and reduced visual dryness (difference: -1.48 [95% CI: 2.24, -0.71]; P<0.001) compared to untreated subjects. Significant benefits were also observed on expert photographic assessments of scaling (difference: -0.89 [95% CI: -1.75, -0.03]; P< 0.05), cupping (difference: -1.50 [95% CI: -2.30, -0.70]; P<0.001), and healthy appearance (difference: -1.44 [95% CI: -2.29, -0.58]; P<0.01); differences in overall healthy appearance were not significant (P=0.51). Subject-rated assessments indicated improvements in cracking, dryness, and flaking in the lip cream group but worsening in untreated subjects. CONCLUSION: These studies indicate that this novel, daily-use lip cream protects against UV radiation, drying, and chapping, which are established environmental RHL triggers.

A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men.

BACKGROUND: An alternative to currently marketed topical minoxidil solutions is desirable. OBJECTIVE: To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol-free foam vehicle in men with androgenetic alopecia (AGA). METHODS: This was a 16-week, double-blind, placebo-controlled trial of 5% minoxidil topical foam (MTF) in 352 men, 18 to 49 years old. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% MTF. RESULTS: At week 16 compared with baseline, there was a statistically significant increase in (1) hair counts in the 5% MTF group versus placebo (P < .0001) and (2) subjective assessment of improved hair loss condition (P < .0001) in the 5% MTF group versus placebo. The 5% MTF was well tolerated over a 52-week period. LIMITATIONS: There was no collection of efficacy data beyond 16 weeks. CONCLUSIONS: We believe that 5% MTF is a safe and effective treatment for men with AGA.