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Topical treatment of erectile dysfunction: randomised double blind placebo controlled trial of cream containing aminophylline, isosorbide dinitrate, and co-dergocrine mesylate

BMJ 1996; 312 doi: (Published 15 June 1996) Cite this as: BMJ 1996;312:1512
  1. Adel Gomaa, professor of pharmacologya,
  2. Mohamed Shalaby, professor of urologya,
  3. Mohamed Osman, associate professor in urologya,
  4. Mohamed Eissa, associate professor in neurologya,
  5. Alaa Eizat, assistant lecturer in urologya,
  6. Mostafy Mahmoud, assistant lecturer in pharmacologya,
  7. Nabiel Mikhail, statisticiana
  1. a Departments of Pharmacology, Urology, Neurology, and Community Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt
  1. Correspondence to: Professor Gomaa.
  • Accepted 6 March 1996


Objective: To examine the effectiveness in treating impotence of topically applied cream containing three vasodilators—aminophylline, isosorbide dinitrate, and co-dergocrine mesylate—which act by different mechanisms.

Design: Randomised double blinded placebo controlled crossover trial over two weeks.

Subjects: 36 men with erectile dysfunction randomly allocated to two equal groups.

Interventions: Active cream containing aminophylline 3%, isosorbide dinitrate 0.25%, and co-dergocrine mesylate 0.05% for one week and placebo for another.

Main outcome measures: Patients' reported experience of penile responses and side effects of treatment in questionnaires. Penile tumescence and arterial flow in the laboratory.

Results: 21 patients reported full erection and satisfactory intercourse with the active cream. Three men reported full erection and satisfactory intercourse with either cream. The active cream was more effective in psychogenic than organic impotence (eight out of nine men with psychogenic impotence achieved a full erection v four out of eight with neurogenic impotence and two out of seven with arterial insufficiency). No major side effects were reported. In the laboratory the active cream increased penile arterial flow (0.19 (SD 0.08) m/s v 0.02 (0.15) m/s with placebo) and induced tumescence in 24 patients.

Conclusions: Topical treatment with a cream containing three different vasodilators might be considered before intracavernous injection of vasoactive agents, particularly in psychogenic impotence.

Key messages

  • In this study a topical cream containing three vasodilators with different mechanisms of action was tested in a double blind placebo controlled crossover trial in 36 impotent men

  • The active cream increased penile arterial flow and induced tumescence in the laboratory, and 21 patients reported full erection and intercourse after a week's treatment

  • The cream was most effective in psychogenic impotence, success rates being lower when the impotence had organic causes

  • This topical treatment should be used before intracavernous agents, especially in psychogenic impotence


  • Funding No additional funding.

  • Conflict of interest None.

  • Accepted 6 March 1996
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