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Recommendations for contraception in clinical trials

  • Published: December 16, 2019
  • Last updated: January 28, 2022

There are EU-common recommendations concerning method of contraception and frequency of pregnancy testing in clinical trials.

The recommendations guide sponsors/investigators concerning which methods of contraception are considered efficient enough to avoid pregnancy in fertile women participating in clinical trials. The document also describes risk mitigation for fertile women and men included in clinical trials.

The recommendations may be be found on the HMA web site, under Key documents list.

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