May 18, 1963

Council on Drugs

JAMA. 1963;184(7):577-579. doi:10.1001/jama.1963.03700200099019

New Drugs and Developments in Therapeutics  Council on Drugs' Statements

Dydrogesterone (Duphaston) 

Summary of Council Opinion.  —Dydrogesterone (9β,10α-Pregna-4,6-diene-3,20-dione) is a synthetic progestogen derived from retro-progesterone. The alteration of steric configuration is believed to account for its pharmacological differences from progesterone and the other progestogens. Although the contradictory clinical evidence available from uncontrolled studies is inadequate to determine the extent to which dydrogesterone may be useful as an oral progestational agent, it appears to be nontoxic and without androgenic or estrogenic activity. No suppression of pituitary activity has been observed clinically.

Actions and Uses.  —See the statement on progesterone under "Ovarian Hormones" in New and Nonofficial Drugs, 1963. Clinical studies have shown that dydrogesterone produces a progestational reaction in the estrogen-primed endometrium, the degree of change being proportional to the dose. Withdrawal bleeding can be produced in the estrogen-primed endometrium, and in the absence of pregnancy. Dydrogesterone differs from other progestogens

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