201901 Contraceptive Clinical Trials Network Sites for Male and Female Contraceptive Development

Contraceptive Development Program seeks Council approval of the recompetition to select clinical sites for the “Contraceptive Clinical Trials Network (CCTN) – a unique network for clinical evaluation of potential new products for male or female contraception.”  Unintended pregnancy rates remain very high (45%) and new methods are needed to address gaps in available contraceptive technology, including the development of methods for men as well as development of safer, more acceptable, and more accessible contraceptive methods for women, including women who are obese or have other risk factors that limit their use of existing methods. NICHD remains the major supportive agency for new contraceptive product development for men and women.  The CCTN is a unique resource for clinical contraceptive development.

Reversible method for male contraception is limited to condoms. In the last cycle of funding, several new products were successfully evaluated for first-in-man safety and these products have progressed to evaluation of safety and surrogate effectiveness markers in repeat-dose Phase I clinical trials. Potential methods include a transdermal gel and two potential oral or injectable compounds for hormonal male contraception. The next cycle will qualify sites to continue development through phase II or phase III clinical evaluation as well as conducting first-in-man studies if promising new hormonal or non-hormonal agents clear preclinical hurdles to qualify for clinical testing.

Safe and acceptable methods are needed for women, especially for women for whom many existing methods are contraindicated. In the last cycle, studies to advance novel products through phase I, II or III have been completed or are ongoing.  The pipeline contains agents that will be safe and effective for obese women as well as novel multipurpose prevention technology products that are designed to protect against both pregnancy and infection with HIV or possibly other pathogens. 

The goal of this initiative is to continue clinical research in contraception development that involves multiple sites with expertise in either male method contraceptive evaluation or female method contraceptive evaluation.

This proposed concept aligns with the NICHD Vision area of Reproduction.

Program Contact

Diana Blithe
Division of Intramural Population Health Research (DIPHR)

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