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USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives

A final industry guidance, "Clinical Drug Interactions Studies with Combined Oral Contraceptives", was released by the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) on June 8, 2023 that replaces the draft guidance released in November 2020.

The purpose of this guidance is to assist sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) in evaluating the drug-drug interaction (DDI) affects their investigational drugs have on combined oral contraceptives (COCs), designing DDI studies, and determining how to communicate DDI study results and risk mitigation strategies in labeling to address potential risks associated with increased or decreased COC exposure.

The guidance focuses solely on metabolic-based interactions between drugs and COCs. Other mechanisms that may cause interactions (such as absorption-based) are not addressed in this guidance but should be considered by sponsors and investigators.

In most cases, COCs contain two synthetic steroid hormones, progestin and estrogen, and are highly effective when used correctly in preventing pregnancy. Drug interaction with concomitant therapies, however, may adversely affect the effectiveness and safety of COCs by altering enzymes involved in progestin and estrogen metabolism.

As COCs are widely used in females of reproductive potential, the DDI potential between an investigational drug and COCs should be evaluated in the drug development phase and communicated in the labeling.

To know more about in which situations the COC & DDI studies should be conducted, click this LINK.


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