The CCTN conducts clinical trials of new contraceptive drugs and devices to develop novel female and male contraceptive methods. This unique network of highly qualified sites and investigators has a proven track record in contraceptive product evaluation, and its Statistical and Clinical Coordinating Center has solid experience with contraceptive product development.
The CCTN is managed through NICHD's Contraceptive Development Program (CDP), part of the Division of Population Health Research, within the Division of Intramural Research. Sites receive funding through contracts at U.S.-based and global university research and medical centers with access to clinical facilities capable of conducting first-in-human and Phase I, II, and III clinical trials. Clinical evaluation conducted through the CCTN forms the evidence base for advancing candidates through a development pathway toward U.S. Food and Drug Administration approval.
CCTN clinical field centers are selected for their capacity to conduct Phase I, II, and III trials of oral, vaginal, intrauterine, injectable, implantable, or topical contraceptive drugs and devices.
In 2022, two clinical trials of new methods for male contraception are actively recruiting. A new clinical trial for evaluation of a device to prevent pregnancy and infection by HIV in women has begun, and a trial evaluating a novel long-acting injectable method for women is actively recruiting. Three additional trials have finished enrollment and are in follow-up or are entering data analysis.
Select CDP research for increasing contraception options for women include:
- Development of a novel progestin- and estradiol-releasing contraceptive vaginal ring that provides effective contraception, without increasing the risk of blood clots and other venous thromboembolism-type conditions, especially in women who have obesity
- Evaluation of a novel vaginal ring that releases agents to prevent pregnancy and infection from sexually transmitted exposure to HIV
- Evaluation of progestin-based compounds delivered as a long-acting injectable method that can prevent pregnancy without increasing the risk of blood clots and other venous thromboembolism-type conditions, especially in women who have obesity or other risk factors that may limit use of estrogen-containing methods
- Development of a mini copper intrauterine device (IUD) that may cause less pain at insertion or less increased bleeding in nulliparous women compared with the current copper IUD available in the United States
Select CDP research for developing hormonal contraception methods for men include:
- Contraceptive efficacy evaluation of a hormonal male contraceptive method (a progestin/testosterone topical gel) in couples using this product to prevent pregnancy
- Development of novel progestogenic androgens, delivered either in a daily oral capsule or as a long-acting injectable formulation, to reduce gonadotropin levels and reversibly inhibit sperm production (spermatogenesis)
NICHD Contact: Diana Blithe