Prolonged development of normal and parthenogenetic postimplantation mouse embryos in vitro

OBJECTIVE: To evaluate the efficacy of intracavernous moxisylyle versus placebo in patients with erectile dysfunction of various origins. To assess the local tolerance and systemic safety of moxisylyte by self-administered injection. METHODS: Multicentre study, comprising two treatment phases: The first, double-blind phase, was conducted in two parallel groups of randomized patients, over a 1-month period (1 injection per week) in the investigator's office; the second phase was conducted under open conditions in the patient's home, over a period of 3 to 11 months. Self-administered injections (1 to 2 per week) were performed using a prefilled syringe containing 10 mg of moxisylyte. RESULTS: Out of 307 patients evaluated during the first phase, the qualitative and quantitative superiority of erectile response induced by moxisylyte compared to placebo was confirmed (p < 0.0001). The stability of the response to moxisylyte was also confirmed on 4 injections, and the frequency of responses compatible with sexual intercourse ranged from 48% to 52% from one injection to another. This efficacy was also maintained during the open phase, as 92% of the 4,487 self-administered injections generated positive erectile responses. The quality of these responses was considered sufficient to allow sexual intercourse after 62% of injections. The local tolerance was considered to be excellent for more than 95% of injections, without any major adverse effects, and a very low risk of prolonged erection and fibrotic reaction. The systemic safety was also considered to be excellent for more than 98% of erections. CONCLUSION: This study confirms the possibility of obtaining an erectile response by intracavernous injection of 10 mg of moxisylyte with a very low incidence of local and systemic adverse effects. It also tends to confirm the superior efficacy of moxisylyte by self-administered injections at home than by injection in the doctor's office.