From Historical Evolution to Modern Revolution

The desire to control female reproduction is not a 20th century phenomenon. Women first began taking substances by mouth to prevent pregnancy as far back as 4,000 years ago, when Chinese women drank mercury—now known to be toxic—to achieve contraception. In the centuries that followed, the Greeks consumed diluted copper ore, the Italians sipped a tea of willow leaves with mule's hoof, the Africans drank gunpowder and camel foam, and Canadian Indians ingested alcohol brewed with dried beaver testicles.

Modern contraception began in 1937, when investigators demonstrated that the female hormone progesterone could halt ovulation in rabbits. Subsequent research replicated this phenomenon—that is, if no egg is released from the ovary, then fertilization and pregnancy cannot occur—in other species.

While this advance was significant, several hurdles remained. Specifically, synthesizing progesterone in the laboratory was both difficult and expensive. Furthermore, natural progesterone could not be given orally because it is destroyed in the digestive system when ingested in its natural form.

In the years that followed, American chemist Russell Marker succeeded in producing progesterone from the roots of wild Mexican yams. Subsequently, in 1949, scientists at the University of Pennsylvania achieved the production of synthetic progestins.

Estrogen, the other hormone that may contribute to pregnancy prevention, works in conjunction with progestin to suppress ovulation, and prevent fertilization and implantation. Continued research led to the development of two synthetic estrogens—mestranol and ethinyl estradiol, both of which can be taken orally.

Large-scale testing of the Pill during the mid-1950s was successful. In 1960, the US Food and Drug Administration approved the first oral contraceptives for marketing in the US. Ortho Pharmaceutical introduced its first birth control pill in 1963. By 1965, the Pill became the nation's leading method of reversible contraception.

The ensuing decades brought continued pill research, discovery and innovation. While early pill formulations contained up to 100 to 150 micrograms (mcg) of estrogen, later studies confirmed that far less hormone was needed to prevent conception. Pills were introduced in the '60s and '70s by Ortho Pharmaceutical Corporation with decreasing estrogen and progestin levels. In 1973, the Company introduced the first progestin-only pill, which contained 350 mcg of norethindrone with no estrogen component.

The next decade saw further progress. Ortho introduced the first multiphasic pill formulations—called biphasics and triphasics —in 1982 and 1984, respectively. In these formulations, the level of progestin changes during the monthly reproductive cycles. In the late '80s, further development resulted in the introduction of formulations that contained one third the original dose of estrogen and one twentieth the original amount of progestin (.035mg EE (estrogen)) and
.5 mg norethindrone (progestin), while still maintaining a 99 percent effectiveness rate.

In the early '90s, the first new progestin in 20 years entered the US market. Norgestimate, a synthetic version of the female hormone progesterone, was introduced by Ortho in a combination pill with a 35 mcg dose of ethinyl estradiol (estrogen), a formulation equally effective in pregnancy prevention.

In 1988, the US Food and Drug Administration recognized several potential noncontraceptive health benefits of pill use, including a decreased incidence of ovarian cancer, endometrial cancer, pelvic inflammatory disease, ovarian cysts, benign breast disease, iron deficiency anemia and dysmenorrhea.

In 1989, an advisory committee to the FDA recognized that the benefits of low-dose oral contraceptive use may outweigh the possible health risks of pill use by healthy, nonsmoking women beyond the age of 40.

In addition to scientific studies related to the Pill, there is also a significant amount of behavioral research of Pill use among American women.This research has shown, for example, that the Pill remains the most popular method of reversible birth control in this country, that it has been used by 80 percent of women at one point during their reproductive lives and that women are now staying on the Pill longer than ever before.

Important Safety Information
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks, and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect against HIV or sexually transmitted diseases.

Please click here for full Prescribing Information.

Important Safety Information.
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks, and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect agains HIV or sexually transmitted diseases.

Please click here for full Prescribing Information.