Four fixed-dose trials, one set of questions
On the DailyMed Levitra label (setid 4e66ad5c-572c-4819-8b6e-6930c33cc210), section Clinical Studies enrolls 2,431 men aged 20 to 83 (mean 57). Mean baseline EF domain score across these trials was 11.8 on a 0 to 30 scale, where lower means more severe disease. The drug beat placebo on EF, SEP2, and SEP3 in all four trials, including men under 45, 45 to 64, and 65 and older.
Sexual stimulation is still required for a response. The diaries counted attempts during sexual activity. They did not count spontaneous erections in a quiet room.
A European general-ED trial (N=803) is described as confirming the North American pattern. This label does not print a second full percentage table for Europe, so this page does not invent one.
North American scores at three months
| Measure at 3 months | 5 mg | 10 mg | 20 mg | Placebo |
|---|---|---|---|---|
| IIEF-EF (on treatment) | 18 | 21 | 21 | 15 |
| SEP2, penetration | 65% | 75% | 80% | 52% |
| SEP3, intercourse | 51% | 64% | 65% | 32% |
The major North American fixed-dose trial evaluated 762 patients (mean age 57, range 20-83). Mean baseline EF scores were 13, 13, 13, and 14 for 5 mg, 10 mg, 20 mg, and placebo. The on-treatment means below are not change-from-baseline shortcuts. Improvement at those doses was maintained at 6 months in this trial.
Placebo was not a zero. SEP2 on placebo was 52%, and SEP3 was 32%. A review that claims the sugar pill did nothing is not reading this table. A review that turns 65% SEP3 on 20 mg into a personal guarantee is not reading it either.
Diabetes and prostatectomy, where the margin thins
The diabetes trial (n=439; ages 33-81) used 10 mg and 20 mg only. EF scores were 17 and 19 versus 13 on placebo. SEP2 was 61% and 64% versus 36%. SEP3 was 49% and 54% versus 23%. Directionally the same drug. Numerically a lower ceiling than the general-ED table.
After radical prostatectomy (n=427; ages 44-77), EF scores were 15 on both 10 mg and 20 mg versus 9 on placebo. SEP2 was 47% and 48% versus 22%. SEP3 was 37% on 10 mg and 34% on 20 mg versus 10% on placebo. In that cohort the higher strength did not buy a higher SEP3 mean. Climbing the dose because a surgery review 'failed' is not what this table teaches.
Both subgroups are reasons to keep expectations specific. They are not reasons to skip the nitrate check or to double a tablet the same night.
The QT study that belongs in any honest review
Efficacy trials are not the whole safety file. Electrophysiology on this label is a single-dose crossover in 59 healthy men aged 45 to 60, comparing 10 mg, 80 mg, placebo, and moxifloxacin 400 mg. QT was read at one hour, near the average peak. Mean Fridericia QTc change versus placebo was 8 msec (90% CI 6 to 9) at 10 mg and 10 msec (90% CI 8 to 11) at 80 mg. Moxifloxacin was 8 msec (90% CI 6 to 9). The study was not built to declare one drug statistically larger than the other. The clinical impact of these changes is listed as unknown.
The 80 mg dose is four times the maximum recommended dose. It was chosen because plasma levels at that dose cover what happens when 5 mg is taken with ritonavir 600 mg twice daily. A separate study in 44 healthy volunteers found a placebo-subtracted QTcF change of 5 msec after 10 mg alone and 9 msec when 10 mg was combined with gatifloxacin 400 mg. The effects added.
The prescribing consequence is concrete. Patients taking Class IA agents (quinidine, procainamide) or Class III agents (amiodarone, sotalol), or who have congenital QT prolongation, should avoid LEVITRA. A star rating that never names those drugs has not finished the review.
What search-result reviews leave out
Uncontrolled comments mix heavy dinners, counterfeit blisters, and expectation. High-fat meals on this label cut Cmax by 18% to 50%. A thin first hour after that meal can impersonate a failed product. Fix the plate before you trust a one-star story. Timing rules are on the user guide.
Nitrate use, regularly or intermittently, is contraindicated, and so are nitric oxide donors. In 18 healthy subjects, extra blood-pressure effects appeared when 20 mg was given 1 or 4 hours before 0.4 mg sublingual nitroglycerin. Additional changes were not detected at a 24-hour gap. The contraindication section still says a suitable interval for safe nitrate administration has not been determined. Do not turn the healthy-volunteer gap into a home timer.
Sponsored review counts and percent-off tiles are not these four trials. If the remaining job is a licensed pharmacy rather than a score, use the FDA consumer update on buying medicines safely from an online pharmacy and the compound page. This URL does not quote cash retail prices.
Questions people ask next
How many controlled trials are summarized? Four major fixed-dose, placebo-controlled trials, 2,431 men, endpoints at 3 months, plus a confirming European general-ED trial (N=803) without a second full percentage grid on this label.
What did SEP3 measure? The per-patient rate of maintaining an erection long enough for successful intercourse. In the North American trial that was 51%, 64%, and 65% on 5, 10, and 20 mg, versus 32% on placebo.
Did 20 mg always beat 10 mg? Not in every cell. After prostatectomy, SEP3 was 34% on 20 mg and 37% on 10 mg. Dose climbs belong to the prescriber after a fair trial, not to a forum average.
Do these percentages apply if I take nitrates? No. Nitrates stay contraindicated. Efficacy tables are not a workaround.
Why is a QT study on a reviews page? Because a review that cites only intercourse rates skips the avoid list: Class IA and Class III antiarrhythmics, and congenital long QT.
Where is how to take the tablet? The user guide.