Mestranol/noretynodrel

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Enovid
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Mestranol/noretynodrel
Norethynodrel
Progestogen
Clinical data
Trade namesEnavid, Enovid
Routes of
administration
By mouth
ATC code
Legal status
Legal status
  • Discontinued
Identifiers
CAS Number
PubChem CID
CompTox Dashboard (EPA)

Mestranol/norethynodrel was the first

G. D. Searle & Company, it was first approved on June 10, 1957, by the U.S. Food and Drug Administration for treatment of menstrual disorders.[1] The FDA approved an additional indication for use as a contraceptive on June 23, 1960, though it only became legally prescribable nationwide and regardless of the woman's marital status after Eisenstadt v. Baird in 1972.[2][3][4][5]
In 1961, it was approved as a contraceptive in the UK and in Canada.[6][7]

Medical uses

Mestranol/noretynodrel was indicated in the treatment of

gynecological and menstrual disorders. Originally it was not legal to use contraception so it was marketed for menstrual relief with the side effect of inability to conceive.[8] It has also been used to suppress lactation and to treat endometriosis in women.[9][10]

Available forms

The medication contained 0.15 mg mestranol and 10 mg noretynodrel.[8] Additional formulations containing 0.075 mg mestranol and 5 mg noretynodrel as well as 0.1 mg mestranol and 2.5 mg noretynodrel were subsequently introduced.[8] One formulation also contained 0.075 mg mestranol and 3 mg noretynodrel.[8]

History

Creation

Enovid was first manufactured when scientists isolated progesterone from diosgenin, then removed 19-carbon from the molecule. This new form of progesterone had higher progestational activity, which prevented pregnancy.[11]

Social impact

Initially sold in 1957, Enovid was first marketed as a treatment for gynecological disorders. In 1960, its sale as an oral contraceptive was approved by the FDA. This was seen as a major improvement to contraceptives as a whole, being preferred over other methods such as condoms and diaphragms.[12]

Complications and legal proceedings

The first published case report of a

patient package inserts with oral contraceptives to explain their possible side effects and risks to help facilitate informed consent.[18][19][20] Today's standard dose oral contraceptives contain an estrogen dose that is one third lower than the first marketed oral contraceptive and contain lower doses of different, more potent progestins in a variety of formulations.[15][17][21]

Enovid was discontinued in the U.S. in 1988, along with other first-generation high-estrogen COCPs.[22][23]

See also

References

  1. ^ Junod SW (1998). "FDA's Approval of the First Oral Contraceptive, Enovid". Histories of Product Regulation. Update (bimonthly publication of the Food and Drug Law Institute). U.S. Food and Drug Administration. Archived from the original on 14 January 2012.
  2. ^ "FDA Approved Drug Products". FDA.
  3. ^
    PMID 11995593
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  12. . Retrieved 2023-11-29.
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  18. ^ FDA (June 11, 1970). "Statement of policy concerning oral contraceptive labeling directed to users". Federal Register. 35 (113): 9001–9003.
  19. ^ FDA (January 31, 1978). "Oral contraceptives; requirement for labeling directed to the patient". Federal Register. 43 (21): 4313–4334.
  20. ^ FDA (May 25, 1989). "Oral contraceptives; patient package insert requirement". Federal Register. 54 (100): 22585–22588.
  21. .
  22. ^ "Searle, 2 others to stop making high-estrogen pill". St. Louis Post-Dispatch. Reuters News Service. 1988-04-15. pp. 7D. Retrieved 2009-08-29.
  23. ^ "High-estrogen 'pill' going off market". San Jose Mercury News. 1988-04-15. Retrieved 2009-08-29.

Further reading

  • Snider S. "The Pill: 30 Years of Safety Concerns".
    OCLC 25936326
    .
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