The process of developing new medicines and medical devices requires many years of research and many millions of dollars. In many countries, before any medical product can come to market, it must be vetted and approved by regulatory agency of the federal government. These agencies typically make their decisions based on the results of formal clinical trials. Clinical trials are research studies in human subjects designed to answer specific questions about the dose range, safety and effectiveness of a novel treatment. Trials are divided into four phases; a new medicine may be approved for use by the general public after completion of the third phase.

This lengthy development and testing process means that the public often hears about innovative medicines many years before there is a product available for purchase. There have been press reports of imminently available male contraceptives for the past 15 years! So what is closest to market? Here is a breakdown of what’s in the male contraceptive development pipeline, and how far along each method is.

Male hormonal contraceptives	Various formulations with various delivery mechanisms have completed Phase II clinical trials; reversibility has been proven in humans	Schering, Organon, World Health Organization, CONRAD, Population Council, Chinese National Research Institute for Family Planning, & over a dozen universities around the world
Intra Vas Device (IVD)	Chinese design of the IVD has completed Phase II trials and is collecting long-term use safety and efficacy data	Chinese National Research Institute for Family Planning
	American IVD design in Phase I trials in 4 centers, reversibility has been tested in primates but not in men	Shepherd Medical Company
RISUG	In Phase III clinical trials in 4 centers in India, reversibility proven in primates but not in men	Indian Medical Research Council
Adjudin	Toxicity and teratogenicity tests complete, concept proven in murine models, researchers are streamlining the manufacturing process	Population Council in New York
External heat (wet heat)	Concept proven in large-scale but informal human studies in India during the 1950s	Not currently being researched
Internal heat (suspensories)	Concept proven in small-scale human studies, researchers investigating safety of long-term use	Centre d’Etudes et de Conservation des Oeufs et du Sperme humain (CECOS) Midi-Pyrenees in Toulouse, France
“Dry orgasm” pill	Drug candidates identified which may block the contractions of the vas deferens, not yet tested in vivo in any animal model	Kings College London
Sperm motion blockers	Genes for sperm-specific calcium ion exchange channels identified, drugs which block their action being sought	Harvard University
	Newly identified sperm tail energy carrier protein (SFEC1) involved in glycolysis which may be a good target for a small-molecule drug	University of Virginia
	Novel sperm tail protein (Cα-s) identified, drugs sought to block its action	University of Massachusetts Medical Center and Spermatech
Sperm-surface enzyme blocker	Enzymes involved in sperm-egg binding are still being identified, and drugs which will bind to each of them being sought	Norfolk State University
Immunocontraceptives	An eppin immunocontraceptive has been tested in monkeys	University of North Carolina at Chapel Hill
	An LDH-C4 immunocontraceptive has been tested in mice	Northwestern University, various research institutes in China