***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data BACKGROUND Many women discontinue their use of hormonal contraception , and even those who continue so may have difficulty using oral contraceptive pills consistently . New delivery systems , including the vaginal ring , may be easier to use , but user acceptability and satisfaction with these new methods may be affected by women 's experience with their bodies . MATERIAL S AND METHODS Data for this study were collected as part of a r and omized clinical trial on 201 women comparing immediate start of vaginal ring use with immediate start of low-dose oral contraceptive use .  We assessed user satisfaction and method continuation 3 months after ring or pill initiation . RESULTS At 3 months , 174 of 201 subjects ( 87 % ) had follow-up interviews . Among the 174 study participants with follow-up data , 61 % of ring subjects and 34 % of pill subjects were very satisfied with their methods ( p=.003 ) . For posttrial contraception , 79 % of ring subjects chose to continue with the ring whereas 59 % of pill subjects chose to continue with the pill ( p<.001 ) . Women who reported greater comfort in touching their genitals , greater frequency of masturbation , more comfort with intercourse and past use of vaginal contraceptives and products were not more likely than others to be satisfied with the ring or to continue using it for birth control . CONCLUSION Women who were allocated to vaginal ring use , regardless of their baseline characteristics or behavior , were likely to be highly satisfied with the method and to continue its use We investigated the effect of antimycotic co-medication on the systemic exposure to  etonogestrel ( ENG ) and  ethinylestradiol ( EE )  released from the contraceptive vaginal ring , NuvaRing . Different formulations of miconazole nitrate and single as well as multiple dosing were investigated during two separate r and omized , open-label , crossover studies . The first study recruited 12 women to compare the effects of co-use of NuvaRing and a single dose of antimycotic to NuvaRing alone . The second study recruited 14 women to compare the effects of multiple doses of an antimycotic vaginal suppository to an antimycotic vaginal cream equivalent . Co-administration of all three antimycotic formulations result ed in a slight increase in systemic exposure to ENG and EE over time , with suppositories having a more pronounced effect than a cream formulation in the multiple-dosing study . The increases in serum levels observed with the different antimycotic formulations are not expected to compromise NuvaRing 's contraceptive efficacy or tolerability OBJECTIVE To assess the effects of the combined contraceptive vaginal ring NuvaRing on ovarian function . DESIGN R and omized , open-label , crossover study . SETTING Clinical pharmacology unit . PARTICIPANT(S ) Sixteen healthy female volunteers . INTERVENTION(S ) Group 1 : one cycle of combined oral contraceptive containing desogestrel ( 150 microg ) and ethinyl estradiol ( 30 microg ) ( desogestrel/EE COC ) , followed by a NuvaRing treatment period . Group 2 : NuvaRing treatment period followed by a cycle of desogestrel/EE COC . MAIN OUTCOME MEASURE(S ) Follicular diameter , serum hormone concentrations ( follicle-stimulating hormone , 17beta estradiol , luteinizing hormone , and progesterone ) , and endometrial thickness . RESULT ( S ) NuvaRing use for the recommended period of 3 weeks result ed in complete inhibition of ovulation , as assessed by vaginal ultrasound ( follicular diameter ) and by serum luteinizing hormone and progesterone concentrations . Inhibition of ovulation was maintained for an additional 2 weeks of NuvaRing use . Ovarian suppression between the groups was comparable . Furthermore , ovarian suppression after 3 weeks of NuvaRing use was comparable to that on day 21 of DGS/EE COC intake . NuvaRing was well tolerated . CONCLUSION ( S ) NuvaRing completely inhibited ovulation throughout the normal 3-week period and the extended period of use . Ovarian suppression was comparable to that with desogestrel/EE COC Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity OBJECTIVE : To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders . METHODS : This r and omized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users . Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection . During the study period , participants assigned the intervention received a daily reminder text message .  Eighty-two women were assigned r and omly to detect a 1.6±2.0 pill difference ( 90 % power , 5 % & agr ; , 15 % dropout ) . RESULTS : Participants were 79 % white , non-Hispanic , 99 % high school graduates , and 99 % nulliparous with a mean age of 22 years . Most reported condom use  with past coital activity , and more than half reported prior emergency contraception use . The mean number of missed pills per cycle did not differ significantly between the groups : 4.9±3.0 for the text-message group and 4.6±3.5 for the control group ( P=.60 ) . The number of missed pills per cycle increased over the course of the study , but this pattern did not increase differentially between the groups . Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries . Despite poor pill-taking , there were no pregnancies . CONCLUSION : Daily text-message reminders did not improve oral contraceptive pill adherence . Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group , the rate of missed pills when measured objective ly was still very high in both groups . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00733707 . LEVEL OF EVIDENCE : BACKGROUND NuvaRing is a combined contraceptive vaginal ring design ed for 3 weeks continuous use followed by a 1 week ring-free period . The present study evaluated  ovarian function in women who were instructed to either adhere to , or deviate from , the recommended regimen of use . METHODS In this open-label , r and omized study , 45 women aged between 18 and 35 years used NuvaRing  for one cycle in which the ring was used according to the recommended regimen . Women in group A ( n = 15 ) then continued with a ' normal ' 3 week period of ring use after which the restoration of ovarian function-i.e . the time to ovulation-for each woman was determined by daily vaginal ultrasound and serum hormone levels . For women in group B ( n = 15 ) , the second cycle consisted of only 3 consecutive days of ring use , after which each woman was monitored until ovulation . Women in group C ( n = 15 ) were not permitted to start a second ' normal ' cycle until a follicle with a diameter of 13 mm was observed by vaginal ultrasound ; subsequently , the development of these follicles during the second cycle of ring use was monitored daily . RESULTS Irrespective of the length of the second cycle , 3 weeks ( group A ) versus 3 days ( group B ) , a new cohort of follicles needed to be recruited and the time to ovulation after ring removal was similar ( 19 versus 17 days ) . The median time needed to develop a follicle up to 13 mm in diameter ( group C ) was 11 days ( range 8 - 21 days ) ; none of the women ovulated after insertion of the second ring . CONCLUSION NuvaRing is a highly effective , reversible method of hormonal contraception . Ovulation , at least until the stage of a 13 mm dominant follicle , is prevented and as little as 3 consecutive days of NuvaRing use interferes with follicle growth Abstract Background : The only available contraceptive patch , Ortho Evra ® , delivers a relatively high dose of estrogen . Material s and methods : Three transdermal contraceptive delivery systems ( TCDS ) containing low doses of ethinylestradiol ( EE ) and levonorgestrel ( LNG ) were evaluated in two open-label r and omized trials . In a phase 1 , two-period , cross-over trial , AG200 - 12.5 and AG200LE were compared with a 150 μg LNG/30 μg EE oral contraceptive ( OC ) ( Levlen ® ) in 39 women . In a phase 2 , parallel-group , multicenter , three-cycle study , AG200LE , AG200 - 12.5 and a higher-dose formulation , AG200 - 15 , were evaluated in 123 women . Results : In Study 1 , mean steady-state plasma concentrations ( Css , pg/mL ) for the TCDS were 17 pg/mL to 26 pg/mL for EE and 1117 pg/mL to 1505 pg/mL for LNG ( for AG200LE and AG200 - 12.5 respectively ) . Maximum concentration ( Cmax ) and Css for both analytes were significantly lower than for Levlen . In both studies , the Css levels for EE and LNG in all groups were within the ranges reported for low-dose OCs . Cycle control for AG200 - 15 , assessed by breakthrough bleeding and spotting episodes as well as number of days of unscheduled bleeding and /or spotting , was similar to that reported for low-dose OCs . Most adverse events were considered mild to moderate in intensity . The incidence of patches falling off was < 2 % . Conclusions : All three patches exhibited excellent safety and wearability profiles while maintaining plasma drug levels required for ovulation suppression and adequate cycle control . A slight increase in the EE dose in AG200 - 15 still places this TCDS within the range of low-dose OCs , with EE exposure much lower than reported for Ortho Evra . AG200 - 15 was selected for further testing in phase 3 studies This open-label , r and omized study compared the pharmacokinetics of ethinylest 
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Effectiveness was not significantly different for the methods compared .
The patch could lead to more discontinuation than the COC .
The patch group had better compliance than the COC group .
Patch users had more side effects than the COC group .
Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge .