Target product profiles for development of novel male contraceptive methods

Overview

Men’s participation in contraception and family planning remains limited and is primarily confined to male condoms, vasectomy and withdrawal. To expand men’s contraceptive choices, efforts are underway to develop safe, effective and reversible novel male contraceptive methods and delivery systems. In line with its normative mandate, WHO has developed its first Target Product Profiles (TPPs) for novel male contraceptives (NMCs). The TPPs describe the minimal and optimal preferred characteristics of new male contraceptive products and are intended to guide product development, introduction, regulatory review and post-introduction monitoring of reversible male contraceptive methods.

The profiles address three modes of action: suppression of spermatogenesis, inhibition of sperm function, and blockade of sperm transmission or transport. For each approach, they establish performance parameters and criteria relating to characteristics such as contraceptive efficacy, safety, reversibility and acceptability, providing a common framework to support the development and assessment of novel male contraceptive products.