Serendipity in the search for “morning-after pills” led to clomiphene for the induction of ovulation

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VOLUME 1, ISSUE 1, P3-13

Author:

V. Craig Jordan, C.M.G., O.B.E., Ph.D., D.Sc., F.Med.Sci.

Abstract:

The approval of the oral contraceptive on June 23, 1960, by the United States Food and Drug Administration (FDA), changed society forever. For the first time, a pill designed and tested by men, supported by influential women, allowed women to control their fertility. For the first time, the FDA approved a medicine to be taken by humans without a disease. The chance discovery of a new group of medicines called nonsteroidal antiestrogens, created an opportunity for the pharmaceutical industry. These compounds were shown to be postcoital antifertility agents in rats and mice. In the 1960s, the development of a “morning-after pill” would have had an enormous market. Numerous companies focused discovery efforts to evaluate the development of their patented nonsteroidal antiestrogens: Merrell (clomiphene), Upjohn (U-11,100A), and ICI Pharmaceutical Division (ICI46,474). However, the antifertility effects of antiestrogens in rats and mice does not mean that the new medicine would be an antifertility agent in women. In this case, clomiphene did exactly the opposite of what it was predicted to prevent. Clomiphene became the first medicine to induce ovulation in subfertile women. This article describes the twists and turns of drug discovery and development over the past half century. The conclusion emphasizes the evolution of drug development over decades, based on fashions in medical research and discoveries in clinical pharmacology. As a result, new uses for old molecules, that started life as “nonsteroidal antiestrogens,” have revolutionized women’s health as members of the new group of medicines called selective estrogen receptor modulators.

Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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