CCTN - COORDINATION OF CLINICAL TRIALS OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

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The mission of the Contraceptive Clinical Trials Network (CCTN) is to develop protocols and conduct clinicals trials that will assist in product development with the end goal to provide effective and safe contraception for women, including special populations such as obese women.Coordinate protocol development, clinical trials, monitoring, and data analysis of clinical studies of new female products evaluated by Contraceptive Clinical Trials Network (CCTN), including a Statistical and Clinical Coordinating Center (SCCC). Each drug or device possibly will provide contraception with lower potentially serious side effects, especially obese women. The objective of this task order is to obtain valid and reliable data to determine the contraceptive efficacy and safety of investigational drugs and devices for use in obese and non-obese women of reproductive age. In addition to clinical evaluation and monitoring, the work consists of database preparation, data analysis and preparation of the final Clinical Study Reports associated with the approved protocols. This task order will coordination of protocol development, clinical trial coordination, monitoring, data analysis and clinical study reports for designated promising new products. All efforts must be in compliance with Good Clinical Practice as specified by the current Food and Drug Administration (FDA) regulations and the final Clinical Study Reports will serve as documents in support of FDA approval of the drugs and devices. Examples include: 1. Low dose oral progesterone receptor modulator (PRMs), such as ulipristal acetate (UPA), which inhibits ovulation and causes amenorrhea. 2. Nestorone/Etradiol vaginal ring 3. Copper IUD, associated with bleeding 4. Levonorgestrel butanoate injectable method