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Styles of sexual expression in women: clinical implications of multivaritanalyses.

Two different multivariate techniques were applied to self-reported trait and behavioral data concerning sexual behavior from a sample of North American women. Canonical correlation delineated three styles in which certain demographic attributes and cognitive indices of sexual arousal were related to forms of sexual expression. The first style was characterized by respondents who experienced high rates of intercourse and orgasm in a cohabitation arrangement but who did not necessarily report satisfaction with their sexual responsivity. A second style was characterized by older women currently without partners who expressed a liking for erotic literature and media, direct genital stimulation, and frequent masturbation but who were dissatisfied with their sexual responsivity. The third style, which included respondents most satisfied with their sexual responsivity, was characterized by women who were more aware of physiological changes during sexual arousal and who enjoyed gently seductive erotic activities, breast stimulation, and genital stimulation. A discriminant analysis showed that those women who were most highly satisfied with their sexual responsivity experienced frequent intercourse and orgasm consistency, enjoyed gently seductive erotic activities and breast stimulation, but were unresponsive to erotic literature and media. A second discriminant analysis showed that women who achieved orgasm most consistently were older, were more aware of physiological changes during sexual arousal, reported higher frequencies of masturbation and intercourse, and were less likely to be aroused by erotic preliminaries. These results are discussed within the context of the literature on the treatment and prevention of sexual dysfunction.

Adolescent↗

Sexual activity in hypertensive men treated with valsartan or carvedilol: a crossover study.

The aim of this study was to compare the effect of antihypertensive treatment with valsartan or cavedilol on sexual activity in hypertensive men who were never treated for hypertension. A total of 160 newly diagnosed hypertensive men (diastolic blood pressure [DBP] > or = 95 mm Hg and < 110 mm Hg), aged 40 to 49 years, all married and without any previous sexual disfunction, were enrolled. After a 4-week placebo period, the patients were divided into two groups: a) 120 patients were randomized to receive carvedilol 50 mg once daily or valsartan 80 mg once daily for 16 weeks according to a double-blind, cross-over design; after another 4-week placebo period, patients were crossed over to the alternative regimen for a further 16 weeks; b) 40 patients were treated with placebo according to a single-blind design for 16 weeks. At the screening visit and every 4 weeks thereafter, blood pressure (BP) was evaluated and patients were interviewed by a questionnaire about their sexual activity. Blood pressure was significantly lowered by both treatments, with a 48% of normalization with valsartan and 45% with carvedilol. During the first month of therapy, sexual activity (assessed as number of sexual intercourse episodes per month) declined with both drugs as compared with baseline, although the decrease was statistically significant in the carvedilol (from 8.2 to 4.4 sexual intercourse episodes, P < .01) but not in the valsartan-treated patients (from 8.3 to 6.6 sexual intercourse episodes, not significant). Ongoing with the treatment the sexual activity further worsened with carvedilol (3.7 sexual intercourse episodes per month) while fully recovered and also improved with valsartan (10.2 sexual intercourse episodes per month). The results were confirmed by the cross-over. Erectile dysfunction was a complaint of 15 patients with carvedilol (13.5%), one patient with valsartan (0.9%), and one patient in the placebo group. These findings suggest that carvedilol induces a chronic worsening of sexual activity, whereas valsartan not only does not significantly worsen sexual activity but may even improve it.

Adult↗

Sexual function in hypertensive males treated with lisinopril or atenolol: a cross-over study.

To evaluate the effect of antihypertensive treatment on sexual activity, 90 hypertensive men, aged 40 to 49 years, all married and without history of sexual dysfunction were treated with 100 mg of atenolol or 20 mg of lisinopril for 16 weeks, according to a double-blind, randomized, cross-over design. During the first month of therapy, sexual activity, assessed as number of sexual intercourse episodes per month, significantly declined with both atenolol (from 7.8 +/- 4.3 to 4.5 +/- 2.8, P < .01 v placebo) and lisinopril (from 7.1 +/- 4.0 to 5.0 +/- 2.5, P < .05 v placebo). Ongoing with the treatment, sexual activity tended toward recovery in the lisinopril (7.7 +/- 4.0 sexual intercourse episodes per month, P = NS v placebo), but not in the atenolol group (4.2 +/- 2.8, P < .01 v placebo), with a statistically significant difference between the two drugs (P < .01). The percentage of patients who complained of sexual dysfunction symptoms was significantly higher in the atenolol- than in the lisinopril-treated group (17% v 3%, P < .05). These findings suggest that atenolol induces a chronic worsening of sexual activity, whereas lisinopril causes only a temporary decline.

Adult↗

The probability of conception on different days of the cycle with respect to ovulation: an overview.

Several mathematical models have been developed over the past thirty years to investigate how the probability of conception changes on the different days of the cycle with respect to ovulation. A problem general to all models is to estimate the day of ovulation. Since the most fertile days are those close to ovulation, less precise estimates of this event will lead to less accurate estimates of the probability of conception on a given day of the cycle. Given that a reference point for ovulation is available, the first model considered conception as dependent only on the timing of intercourse. Conception was found to be most likely to occur on only six days in each cycle. However, the model is biologically unrealistic because it assumes that all ova can be fertilized and lead to a viable pregnancy. There are other factors that affect the probability of conception, including whether the ovum is viable or not. Recent models have extended the idea of cycle viability to allow for differences between cycles within couples and for the introduction of couple specific covariates. In a second group of models the probability of conception depends mainly on the time of intercourse and the survival times of sperm and ovum. A graphical summary of the results available in the literature is presented. Conception probabilities have been found to be significantly different from zero from five days before ovulation to the day of ovulation itself. On average, less than half of the cycles are viable in women, although recent studies suggest that different cycle viability between women should be taken into account. Survival times for sperm and the ovum have been estimated to be 1.4 days and 0.7 days, respectively. Sperm would have a 5% probability of surviving more than 4.4 days and a 1% probability of surviving more than 6.8 days.

Female↗

Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients.

STUDY DESIGN: A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients. OBJECTIVES: To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg. SETTING: Neurourology Section, Careggi Hospital, Florence, Italy. METHODS: During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3. RESULTS: Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner. CONCLUSION: Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients. SPONSORSHIP: This study was not sponsored.

Carbolines↗

[Postcoital IUD insertion, a review].

Following the development of hormonal interception after coitus the post-coital insertion of an intrauterine contraceptive device was proposed by Tatum . The advantage of this treatment is the avoidance of the ingestion of large doses of estrogen which causes much nausea and vomiting although it is a very effective post-coital method of contraception. The recently proposed alternative administration of 200 micrograms Ethynol Estradiol combined with 2 mg of DL norgesterol in 2 equal doses at 12 hour intervals has the same disadvantage of a high percentage of side effects. The post-coital insertion of an intrauterine contraceptive device is the first method which is effective up to five days following unprotected intercourse which is three days longer than treatment by estrogen. In addition the method can be offered to women who would want to continue to wear the intrauterine contraceptive device for long term contraception. The disadvantage of the post-coital insertion of an intrauterine contraceptive device is the ability of serious complications if the patient has a vaginal or venereal infection or an asymptomatic cervicitis or salpingitis. Following appropriate physical examination women who present themselves for post-coital treatment are selected. Cases of rape are usually not suitable for treatment with intrauterine contraceptives devices. However, when cases of rape are seen early enough the appropriate investigations may be done and the treatment with the intrauterine device started within five days. The potential risk of future infertility must be considered since salpingitis is 7 times more common in nulliparous wearers of intrauterine devices than in nulliparous non-wearers. Young sexually active nulliparous women especially of lower socio economic background are patients with a high risk. Over 70% of the women who present themselves for interception treatment are nulliparous.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Factors that predict how women label their own childhood sexual abuse.

Despite the psychological impact of child sexual abuse, many victims do not acknowledge that their experiences were "abuse". This study sought to identify factors that predict how women label their own experiences of childhood sexual abuse. This cross-sectional study was conducted in a family medicine clinic with adult female patients. Subjects completed structured interviews about their childhood environment and their sexual abuse history. Logistic regression analysis showed that labeling of abuse was dependent upon intercourse (beta = 7.43, p = .006), the frequency of abuse by the first perpetrator (beta = 5.08, p = .024), and paternal overprotection (beta = 6.69, p = .010). Findings suggest that the severity of abusive acts is most important and an over-protective father may enhance the victim's acknowledgment that sexual touching is abusive.

Adult↗

[Causes for accepting or not accepting contraceptive methods in the immediate postabortion].

OBJECTIVE: To determine the causes that motivate acceptance or not-acceptance of contraceptiva methods in the immediate post abortion period. Material and methods. 191 questionnaires were applied to immediate post abortion patients, in the "Luis Castelazo Ayala" Gynecology and Obstetrics Hospital of the Instituto mexicano del Seguro Social. Patients were divided by two groups: acceptants (n = 75) and not-acceptants (n = 116). Both groups were compared with Student's t test and contrast of proportions. RESULTS: There were not significant differences in the general characteristics of both groups like age, age at menarche, beginning of sexual intercourse, age of marriage or free union, school grade, age at first pregnancy, number of pregnancies, gestational age of the last pregnancy that ended in abortion, previous use of contraceptiva methods and previous experience with them and whether or not they wanted a new pregnancy. The contraceptive method was offered to all patients in the acceptant group. Information was given to 45.33% of them and was considered satisfactory in 75.00%. In contrast, not-acceptants that received information were only 26.72% (p < 0.05) and all of them (100.00%) considered it inadequate (p < 0.05). In 20.68% of the women the method was not offered (p < 0.05). Medical contraindications were present in only 6.03%. The accepted methods were intrauterino device (64.00%), parentheral methods (16.00%), oral contraceptives (13.33%), surgical sterilization (5.33%) and condoms (1.33%). The contraceptive coverage of post abortion patients was 39.27% in this period. CONCLUSIONS: The use of contraceptive methods in post abortion patients can be increased if it is offered systematically to all patients who have had an abortion. Information given to patients must be understandable and sufficient to dissipate fears and ciarify doubts regarding the contraceptive method; contraceptive options must be offered according to the reproductive expectancies and using the informed consent to reinforce the acceptance of the chosen method.

Abortion, Spontaneous↗

[Emergency contraception with levonorgestrel in adolescents].

OBJECTIVE: The aim of the study was to asses effectiveness and adverse reactions in adolescent girls received Postinor (0.75 mg Levonorgestrel) for emergency contraception. METHOD: Forty-two teenage girls with established regular menstrual cycles for 24 months period and 128 intercourses are included. Excluding criteria are: clinical data for gynecological endocrine diseases, other contraceptive methods used and contraindication for using gestagens. The girls received tablets Postinor containing 0.75 mg levonorgestrel in dosage 1 or 2 pills after non-protected sexual contact. Before the study the girls are examined for their knowledge about fertile period of the menstrual cycle, opportunities of hormonal contraception and about their ability to make adequate decisions in unpredicted situations and complications of the unprotected or inadequate protected intercourse. RESULTS: No one pregnancy occurred during the study period. Main first adverse reactions after receiving Postinor were nausea (12.4%) and intermenstrual bleeding (30.9%), persisting up to three days. Systemic adverse reactions reported from the women were breast tenderness (11.2%), dizziness (6.5%) and headache (5.6%). These side effects were mild and did not require treatment. CONCLUSION: Emergency contraception with Levonorgestrel is effective, with less contraindications compared with other emergency contraception methods. Postinor is available and reliable contraceptive medication.

Adolescent↗

Urban to rural routes of HIV infection spread in Ethiopia.

A descriptive survey to identify routes of spread of HIV infection from urban to rural populations was carried out in a rural south-central Ethiopian district. High risk practices for HIV infection and transmission were first documented among rural residing former soldiers, merchants and students. Extramarital intercourse during the previous 3 months was reported by 45-50% of these subgroups. In 25-37%, intercourse with an urban commercial sex worker (CSW) was reported and condom use varied from 10 to 30% among subgroups. The perceived risk for AIDS was low and changes in risk behaviours were minimal. Next, 502 rural males farmers were surveyed. An extramarital sexual contact in the past 3 months was reported by 13.5%, with 7% reporting their most recent contact with an urban CSW. Only 6% of farmers reported using condoms. Awareness of AIDS was reported by 59% and, of these, only 28% perceived they were vulnerable. In this study increased knowledge was associated with more frequent high risk sexual practices. It is concluded that the spread of AIDS into rural communities is occurring as a result of the high frequency of high risk sexual behaviours in specific rural residing subgroups which frequently travel into urban communities in combination with a low background prevalence of high risk practices among the general male farmer population.

Adolescent↗

Estimates of human fertility and pregnancy loss.

OBJECTIVE: To examine the fertility and pregnancy wastage rates in a group of presumably fertile couples. DESIGN: Prospective observational study of 200 couples desiring to achieve pregnancy over 12 menstrual cycles coupled with pregnancy outcome follow-up. SETTING: A university-based obstetrics and gynecological center. PATIENTS: Personal interviews and questionnaires were used to screen couples for entry into the study. Couples were counseled to have intercourse centered on predicted day of ovulation. Phase 1 included the first three cycles in which women collected daily morning urine samples, underwent midcycle postcoital tests, and, if late for their menses, presented for serum hCG testing. Phase 2 encompassed the next nine cycles in which women were contacted monthly by phone and underwent serum hCG testing if menses was delayed. Urine samples from cycles in which clinical (serum hCG) pregnancy did not occur underwent sensitive hCG testing to detect occult pregnancies. Pregnancies were followed until delivery to ascertain outcome. RESULTS: Eighty-two percent of the 200 couples followed for the entire study period conceived. The maximal fertility rate was approximately 30% per cycle in the first two cycles. This rate quickly tapered over the remainder of the study. Pregnancy wastage during phase 1 accounted for 31% of the pregnancies detected. Forty-one percent (15/36) of these losses were seen only by urine hCG testing and were categorized as occult. Eleven of these same patients later achieved clinically recognized conceptions during the study. CONCLUSIONS: These results support the concept that the efficiency of human reproduction is maximum at approximately 30% per cycle. A very significant number of these pregnancies end in spontaneous abortion. In addition, pregnancy loss before missed menses occurs in a significant proportion of women.

Abortion, Spontaneous↗

Intra-uterine insemination or timed intercourse after ovarian stimulation for male subfertility? A controlled study.

In this randomized trial we investigated whether intra-uterine insemination (IUI) in couples with male subfertility leads to a higher probability of conception than timed intercourse after ovarian stimulation with human menopausal gonadotrophin (HMG) and human chorionic gonadotrophin (HCG). A total of 76 couples started 249 cycles, of which 47 were cancelled to prevent multiple pregnancies or hyperstimulation. After 202 completed treatment cycles, 15 pregnancies occurred, 11 after IUI and four after timed intercourse. The pregnancy rate per completed cycle with IUI was 10.3% (95% confidence interval: 5.5-17.5%) and 4.2% (1.2-10.1%) with timed intercourse. Compared with the estimated spontaneous chance to conceive, IUI after ovarian stimulation appeared to be more effective in the first three cycles. We conclude that in subfertile couples with a male factor, IUI tends to improve the probability of conception as compared to timed intercourse when ovarian stimulation is applied, and we advise such treatment for three cycles.

Adult↗

Changes in sexual function after radiotherapy treatment of prostate cancer.

OBJECTIVE: To assess sexual function before and after definitive irradiation for the treatment of cancer of the prostate. PATIENTS AND METHODS: The study comprised 67 patients (mean age 68 years) treated in five radiotherapy departments and assessed with repeated questionnaires about their libido, arousal, frequency and quality of intercourse, and sexual satisfaction. Interviews were obtained before radiotherapy and at the end of the first year after treatment. Sixty-three patients were married and 50 had a sexually effective partner. Forty-six patients presented with another pathology or medical treatment capable of inducing sexual dysfunction. Before radiotherapy, 40 patients were sexually active, with good to acceptable intercourse. RESULTS: Between 10 and 24 months after the end of radiotherapy, no disease progression was observed and prostate-specific antigen levels remained high in only two patients. Sexual function was preserved in 67% of patients but only 50% observed no change. The functional prognosis seemed to be related to the initial frequency and quality of intercourse; more than three times per month, the prognosis remained good, under three per month, it was poor. The patient's age was a predictive factor for the frequency of intercourse. CONCLUSION: Several causes of impairment of sexual function may be associated and can change over a long time. A longer survey should be conducted to analyse the organic response to radiation.

Aged↗

Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study.

INTRODUCTION: Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at-home setting has not been evaluated. AIM: The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg. METHODS: The multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase-2 study enrolled men at least 21 years old with a minimum 3-month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8-10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse. MAIN OUTCOME MEASURES: The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one-minute intervals using a step-down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method. RESULTS: Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing (P = 0.012). Response to tadalafil 10 mg approached significance (P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg (P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg (P = 0.042). Fifty-two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo (P = 0.038). CONCLUSIONS: This stopwatch-based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg.

Adult↗

The social context of drinking, drug use, and unsafe sex in the Boston Young Men Study.

The objective of this study was to evaluate the relation between drinking, drug use, and unprotected anal intercourse in young men who have sex with men. A cross-sectional analysis of first-visit data from a prospective cohort of 508 young gay men recruited from 1993 through 1994 from bars, college campuses, and the Fenway Community Health Center in Boston was performed. The major outcome measures were any unprotected anal intercourse, after drinking and when sober, stratified by type of sexual partner (steady or nonsteady) during the previous 6 months and during the most recent sexual encounter. The average age of the cohort was 23.3 years; 77.6% were white, and 76.4% were in college. These young men had a median of 10.5 male sexual partners in their lifetimes, and 3 sexual partners in the previous 6 months before enrollment. One hundred and thirty-four (26%) reported unprotected anal intercourse during the previous 6 months. Individuals who had unprotected anal intercourse were more likely to have a drinking problem (odds ratio [OR] = 1.95; 95% confidence interval [CI] = 1.26-3.01) and drank more (20.4 ml/day versus 13.9 ml/day; p < or = 0.01), compared with individuals who did not engage in unprotected anal intercourse. Overall, men were significantly less likely to have unprotected anal intercourse after alcohol or drug use, based on a series of paired analysis (OR = 0.27; 95% CI = 0.15-0.48). However, when we stratified by type of sexual partner, men were significantly more likely to have unprotected anal intercourse with their nonsteady sexual partners after drinking than when sober (OR = 4.33; 95% CI = 1.37-13.7), but were significantly less likely to have unprotected anal intercourse with steady partners (OR = 0.27; 95% CI = 0.15-0.48). The patterns observed as already mentioned for drinking were also found for substance use in general. Men who were more likely to have unprotected anal intercourse after substance use were significantly more likely to have a drinking problem (OR = 7.65; 95% CI = 2.34-24.59). These results suggest that the role of alcohol and unsafe sex in young gay men is complex, with the role of situational factors of paramount importance. Alcohol and substance use interventions designed to reduce HIV risk need to specify the role of substance use in the sexual context to be successful.

Adult↗

[Emergency contraception].

A specific formulation has been approved for use in Italy for emergency contraception (EC) in 2000. As expected, marketing of this levonorgestrel (LNG) only formulation has been accompanied by an increased interest and, often, controversies leading to even strong opposition on the part of those ethically opposed to the use of any method that may act after fertilization. At present, several trials on the exact mechanism of action and safety have been conducted, giving good reason for simplifying access, providing it free or over the counter, in several European countries. EC, also known as ''the morning after pill'' or postcoital contraception, is a modality of preventing the establishment of an unwanted pregnancy after unprotected intercourse and thus, probably, of reducing the number of voluntary pregnancy terminations. Two different forms are available: the hormonal and the intrauterine. Hormonal estrogen only EC was first proposed in the 60s and in 1974 Yuzpe following his studies proposed for the first time his combined regimen, that showed better efficacy and lower side effects. More recently, a new regimen, consisting of LNG, administered alone at the dose of 1.5 mg, was introduced and found in clinical trials to be more effective than the Yuzpe regimen, if taken as early as possible, within 72 h, thereby replacing the latter in common use. Mechanism of action of both hormonal preparations used for EC is inhibiting or delaying ovulation, therefore a prefertilization action. No effect has been reported on the process of implantation nor on an ongoing pregnancy. The WHO have developed a third regimen based on the use of the selective progesterone receptor modulator (antiprogestin) Mifepristone and conducted trials with different dosages, reporting similar efficacy and safety compared to LNG. Intrauterine EC was first proposed by Lippes in 1976. It has the advantage of being effective if inserted within 5 days after unprotected intercourse and the disadvantage of a greater complexity. In addition, this modality is truly interceptive, acting by preventing implantation. Pregnancy rates reported following EC using a device >300 mm2 of copper are consistently low (0.1-0.2%).

Contraception Behavior↗

First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities: RELY-I.

First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10 mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability--Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10 mg or placebo for 12 weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10 mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10 mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.

Adult↗

Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study.

BACKGROUND: Effective interventions are needed to prevent acquisition of HIV infection in men who have sex with men. To date, no behavioural interventions specifically for this risk group have been tested with HIV infection as the primary outcome. METHODS: This multisite two-group randomised controlled phase IIb trial tested the efficacy of a behavioural intervention in preventing HIV infection among 4295 men who have sex with men. The experimental intervention consisted of ten one-on-one counselling sessions followed by maintenance sessions every 3 months. The standard condition was twice-yearly Project RESPECT individual counselling. Twice-yearly follow-up visits included testing for HIV antibody and assessment of behavioural outcomes. FINDINGS: The rate of acquisition of HIV infection was 18.2% (95% CI -4.7 to 36.0) lower in the intervention group than the standard group. Adjustment for baseline covariates attenuated the intervention effect to 15.7% (-8.4 to 34.4). The effect was more favourable in the first 12-18 months of follow-up. The occurrence of unprotected receptive anal intercourse with HIV-positive and unknown-status partners was 20.5% (10.9 to 29.0) lower in the intervention than in the standard group. INTERPRETATION: The results from the primary analyses allow us to rule out that the experimental intervention is associated with a 35% lower rate of HIV acquisition than in the standard group. The overall estimate of a difference of 18.2%, more favourable estimates of effect in the first 12-18 months, and similar effects on risk behaviours suggest that prevention of HIV infection among men who have sex with men by a behavioural intervention is feasible. Further work should be done to develop more effective interventions.

Adolescent↗