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Study Shows Vardenafil Increased Penile Rigidity & Tumescence in Men With Erectile Function Difficulties.

World Journal of Urology Publishes New Study

WEST HAVEN, Conn., April 10 /PRNewswire/ --

Vardenafil, Bayer's investigational phosphodiesterase-5 (PDE-5) inhibitor for the improvement of erectile function, significantly increased penile rigidity and tumescence in men with mild to moderate erectile difficulties, according to the results of a new study published in the peer-reviewed World Journal of Urology.

"We measured how rigid the penis becomes during an erection (rigidity), as well as how the circumference increases (tumescence). When the rigidity of a penis reaches 60 percent, compared to an incompressible rod (100 percent), it is considered suitable for intercourse," Dr. Theodor Klotz, lecturer and senior consultant for urology at the Weiden Clinic in Germany, explained.

"In this study, both the 10 mg and 20 mg doses of vardenafil significantly increased the amount of tumescence compared to placebo. Vardenafil doubled the total amount of time the penis held a greater than 60 percent rigidity with the 20 mg dose."

The article also provides insights on vardenafil's duration of action, presenting pharmacokinetic data on vardenafil's level of concentration in study subjects' bloodstream over time.

Vardenafil Produced a Longer Duration of Erection Over Placebo

In this randomized, placebo-controlled, double-blind crossover study, 21 volunteers ages 18-60 with mild to moderate difficulty with erectile function received either a single 10 mg or 20 mg dose of vardenafil or placebo. Twenty minutes elapsed before the patients were exposed to 20 minutes of a visual stimulus (video). Penile rigidity and tumescence were measured during the first video screening and two additional 20-minute viewing sessions, with twenty minutes in between each session. Rigidity and tumescence were measured using a RigiScan(TM) device (RigiScan(TM) Ambulatory Rigidity and Tumescence Monitor). The maximum time of measurement was 150 minutes; visual stimulation was provided for 60 minutes total.

"The crossover design of this study adds considerable strength to the findings. Each patient acted as his own control, which reduced the variability of the data," said Dr. Klotz.

The primary endpoint was the total duration of erections with greater than 60 percent rigidity as calculated by RigiScan(TM) software. In the 20 mg vardenafil group, the average length of time of an erection with rigidity greater than 60 percent more than doubled over placebo, reaching 67 minutes at the base of the penis and 45 minutes at the tip (p<0.001). Similarly, 10 mg of vardenafil also produced a significantly longer duration of erection with rigidity greater than 60 percent, lasting 54 minutes and 39 minutes at the base and tip, respectively (p<0.01). Men who received placebo experienced erections with a rigidity of greater than 60 percent for an average of 31 minutes at the base and 17 minutes at the tip.

Pharmacokinetic Profile

The blood concentrations of vardenafil were determined for up to 24 hours. It was found that the concentration of vardenafil gradually declined, with an average half-life of about four hours for both dosage levels.

"Vardenafil is not remaining in a patient's system any longer than it needs to," said Dr. Klotz.

Safety Profile

The study also reported that vardenafil was generally well tolerated, with mild or moderate adverse events occurring in four patients taking the 10 mg dose, two patients taking 20 mg, and in one subject in the placebo group.

Vardenafil is currently being evaluated in Phase III clinical trials, with results expected for publication later this year and completion of Food and Drug Administration (FDA) review in the second half of 2002. Current estimates suggest that more than half of all men in the U.S. over age 40 experience some difficulty with erectile function(1)

Bayer Committed to Men's Health

Bayer Corporation is helping men manage their health through a range of therapies. Bayer has already established itself as a credible force in men's health with Cipro(R) (ciprofloxacin HCl). Other men's health products include One-A-Day(R) Men's High Potency Multivitamin/Multimineral Supplement, and One- A-Day(R) Prostate Health. In addition, Bayer is in the process of launching a recently approved once-yearly implant for the palliative treatment of advanced prostate cancer.

Although best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of health care, life sciences, and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability, and improve people's lives.

Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2000, and is one of Fortune magazine's Most Admired Companies. The company employs 23,200 people. It is a member of the worldwide Bayer Group, a $29 billion international life sciences, polymers, and specialty chemicals group based in Leverkusen, Germany. The Bayer Group (BAYG.DE) stock is a component of the DAX, and Bayer plans to list its stock on the New York Stock Exchange Sept. 26, 2001.


(1) Feldman H, Goldstein I, Hatzichristou D, Krane R, and McKinlay J.

Impotence and its medical and psychosocial correlates: Results of the

Massachusetts Male Aging Study. Journal of Urology, 1994: 151:54-61

(2) Klotz T, Sachse R, Heidrich A, Jockenhovel F, Rohde G, Wensing G,

Horstmann R, Engelmann R. Vardenafil increases penile rigidity and

tumescence in erectile dysfunction patients: A Rigiscan and

pharmacokinetic study. World Journal of Urology, 2001: 19: 32-39

CONTACT: Mary Sawyers of Bayer Corporation, 203-812-3321; Wendy Blackburn of Fleishman-Hillard, 816-512-2295, for Bayer Corporation
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Date:Apr 10, 2001
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