A randomized, double-blind, cross-over, placebo-controlled study of a novel topical lipid-based delivery system of prostaglandin E₁ in the treatment of erectile failure

Authors: Foldvari M.^{1, *}; Wilson T.W.²; Afridi S.K.³; Kudel T.⁴; Quest D.W.⁵

Source: Sexual Dysfunction, Volume 1, Number 2, July 1999 , pp. 99-104(6)

Publisher: Wiley-Blackwell

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Abstract:

Background

A double-blind, randomized, placebo-controlled cross-over trial in a home setting was conducted to determine the feasibility of a topically applied novel lipid-based delivery system of prostaglandin E₁ (PGE₁) formulation.

Method

Thirty men (mean age: 62) with erectile failure of vascular origin, documented by penile duplex-Doppler ultrasonography, and their partners, were included in the study. The primary outcome measure was the achievement of penile erection adequate for vaginal penetration (0–1–2 scale) and the secondary outcome was the rupture of snap-gauge elements (0–1–2–3 broken strings).

Results

Three men (3/28) achieved full erection (rank 2 = erection obtained and intercourse successful) with the active product and none did with placebo (0/28). Responses rated rank 1 (erection obtained but not sufficient for intercourse) were 4/28 for the active and 6/28 for placebo. Results reported by partners indicated fewer placebo responses (6/28; rank 2: 3/28) for active and 4/28 (rank 2: 0/28) for placebo. Snap-gauge element ratings were also similar to patient and partner ranking, but the single patient who reported rupture of all three elements, did so after receiving the active drug. There were no noteworthy adverse effects among patients or partners.

Conclusion

Overall, this trial indicated a 10% response rate to the transdermal PGE₁ preparation, although a significant statistical difference could not be shown.

Keywords: impotence; liposome; prostaglandin E₁; sexual dysfunction; topical

Language: English

Document Type: Research article

Affiliations: 1: College of Pharmacy and Nutrition, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada 2: Department of Medicine, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada 3: Department of Surgery, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada 4: Department of Medical Imaging, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada 5: Department of Pharmacology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada *

Publication date: 1999-07-01