Last update March 26, 2022

Ethinylestradiol + Norethisterone

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Combined oral contraceptive (COC) of estrogen (ethinyl estradiol) and progestogen (norethisterone) in the form of pills for oral use. Daily administration.

Hormonal contraceptives, both combined (COC) and progestogen-only, do not alter the composition of milk, neither in minerals (Mg, Fe, Cu, Ca, P) nor in fats, lactose, proteins or calories. (Urzica 2013, Dórea 2000, 1999 y 1998, Costa 1992)

No short-term or long-term clinical, physical or psychomotor developmental problems have been observed in infants whose mothers were taking a COC (Lopez 2015, Nilsson 1986), except for a few cases published years ago of transient gynecomastia. (Madhavapeddi 1985, Nilsson 1978, Marriq 1974, Curtis 1964)

No study has found negative effects on breast milk production or infant weight gain when COC are started after the first 2, or better 6, weeks postpartum. (Tepper 2015, Bahamondes 2013, Espey 2012)

During lactation progestin-only contraceptives are preferable to those combined with estrogen and, in this case, those with a lower dose of estrogen. (CDC 2016, 2013 y 2010, WHO/OMS 2015, Altshuler 2015, Berens 2015, CLM 2012)

If a COC is taken during lactation, it is advisable not to start it before a month and a half after delivery and monitor milk production through the growth of the infant. (Moretti 2000)

For the first 4-6 weeks postpartum, non-hormonal methods are the first choice, followed by IUDs and progestogen implants. (Berens 2015, Mwalwanda 2013, Rowe 2013, CLM 2012)

The American Academy of Pediatrics states that COC are usually compatible with breastfeeding. (AAP 2001)

ETHINYLESTRADIOL is a synthetic estrogen that has a similar action as estradiol. 

Its pharmacokinetic data (high percentage of protein binding and very wide volume of distribution) explain the negligible or null passage into breast milk observed. (Betrabet 1986, Nilsson 1978)

Estrogens, alone or associated with progestogens, have been used in the treatment of excess milk production(Johnson 2020) and to suppress lactation (Piya 2004, Balmer 1971), although with very little success. (Kaern 1967)

There is low quality evidence that estrogen-containing pills may decrease milk production or the duration of breastfeeding, especially if given during the first few weeks postpartum and with a daily dose equal to or greater than 30 micrograms (0,03 mg) diarios.(WHO 2002, AAP 2001, WHO 1988, Nilsson 1986, Tankeyoon 1984, Díaz 1983, Peralta 1983, Croxatto 1983, Guiloff 1974, Kaern 1967)

NORETHISTERONE (norethindrone) is a progestin derivative of 19-nortestosterone. 

It is excreted in breast milk in clinically significant amount (Betrabet 1987, Toddywalla 1980, Saxena 1977) and no problems have been observed in infants whose mothers took it. (WHO 1994, Shaaban 1991, Giner 1976, Karim 1971)

Plasma levels of these infants were undetectable or very low.(Betrabet 1987)

No alterations have been observed in the amount or composition of breast milk in mothers treated with norethindrone. (Giner 1976)


See below the information of these related products:

Alternatives

  • Desogestrel ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Diaphragm ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Etonogestrel ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Intrauterine Device ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Levonorgestrel (oral, implant, IUD) ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Norethisterone ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Preservative ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ethinylestradiol + Norethisterone in other languages or writings:

Groups

Ethinylestradiol + Norethisterone belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Ethinylestradiol + Norethisterone in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40-60 / 64 %
Molecular weight 296 / 298 daltons
Protein Binding 99 / 99 %
VD 5 - 10 / 4 l/Kg
pKa 10.3 / 17.6 -
Tmax 1.5 ± 0.5 / 1 - 2 hours
8 ± 5 / 8 -10 hours
M/P ratio 0.3 / 0.3 -
Theoretical Dose < 0.000045 / < 0.0004 mg/Kg/d
Relative Dose < 0.54 / < 1.9 %

References

  1. Johnson HM, Eglash A, Mitchell KB, Leeper K, Smillie CM, Moore-Ostby L, Manson N, Simon L; Academy of Breastfeeding Medicine.. ABM Clinical Protocol #32: Management of Hyperlactation. Breastfeed Med. 2020 Mar;15(3):129-134. Abstract Full text (link to original source)
  2. CDC - Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. CDC - MMWR Recommendations & Reports. 2016 Abstract Full text (link to original source) Full text (in our servers)
  3. Lopez LM, Grey TW, Stuebe AM, Chen M, Truitt ST, Gallo MF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev. 2015 Abstract
  4. Tepper NK, Phillips SJ, Kapp N, Gaffield ME, Curtis KM. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2015 Abstract
  5. Berens P, Labbok M; Academy of Breastfeeding Medicine. Protocolo clínico de la ABM n.º 13: Anticoncepción durante la lactancia, revisado en 2015. Breastfeed Med. 2015 Full text (link to original source) Full text (in our servers)
  6. Altshuler AL, Gaffield ME, Kiarie JN. The WHO's medical eligibility criteria for contraceptive use: 20 years of global guidance. Curr Opin Obstet Gynecol. 2015 Abstract Full text (link to original source) Full text (in our servers)
  7. Berens P, Labbok M; Academy of Breastfeeding Medicine. ABM Clinical Protocol #13: Contraception During Breastfeeding, Revised 2015. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  8. OMS. Criterios médicos de elegibilidad para el uso de anticonceptivos Quinta edición. Who Library. 2015 Full text (link to original source) Full text (in our servers)
  9. WHO. Department of Reproductive Health and Research World Health Organization. Medical eligibility criteria for contraceptive use: 20 years of global guidance. WHO/RHR/15.07. 2015 Abstract Full text (link to original source) Full text (in our servers)
  10. CDC. Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). U.S. Selected Practice Recommendations for Contraceptive Use, 2013: adapted from the World Health Organization selected practice recommendations for contraceptive use, 2nd edition. MMWR Recomm Rep. 2013 Abstract Full text (link to original source) Full text (in our servers)
  11. Urzica D, Gales C, Zamfir C, Nechifor M. The influence of oral steroidal contraceptives on magnesium concentration in breast milk. Magnes Res. 2013 Abstract
  12. Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhães A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Abstract Full text (link to original source) Full text (in our servers)
  13. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  14. Mwalwanda CS, Black KI. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. Aust N Z J Obstet Gynaecol. 2013 Abstract
  15. CLM - Comité de Lactancia Materna de la AEP. Preguntas frecuentes sobre lactancia materna. Folleto. 2012 Full text (link to original source) Full text (in our servers)
  16. Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Abstract
  17. Centers for Disease Control and Prevention (CDC). U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep. 2010 Abstract Full text (link to original source) Full text (in our servers)
  18. Piya-Anant M, Worapitaksanond S, Sittichai K, Saechua P, Nomrak A. The combined oral contraceptive pill versus bromocriptine to suppress lactation in puerperium: a randomized double blind study. J Med Assoc Thai. 2004 Jun;87(6):670-3. Abstract
  19. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  20. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  21. Dórea JG. Oral contraceptives do not affect magnesium in breast milk. Int J Gynaecol Obstet. 2000 Abstract
  22. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  23. Dorea JG, Miazaki ES. The effects of oral contraceptive use on iron and copper concentrations in breast milk. Fertil Steril. 1999 Abstract
  24. Dorea JG, Myazaki E. Calcium and phosphorus in milk of Brazilian mothers using oral contraceptives. J Am Coll Nutr. 1998 Abstract
  25. WHO. Progestogen-only contraceptives during lactation: I. Infant growth. World Health Organization Task force for Epidemiological Research on Reproductive Health; Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1994 Abstract
  26. WHO. Progestogen-only contraceptives during lactation: II. Infant development. World Health Organization, Task Force for Epidemiological Research on Reproductive Health; Special Programme of Research, Development, and Research Training in Human Reproduction. Contraception. 1994 Abstract
  27. Costa TH, Dorea JG. Concentration of fat, protein, lactose and energy in milk of mothers using hormonal contraceptives. Ann Trop Paediatr. 1992 Abstract
  28. Shaaban MM. Contraception with progestogens and progesterone during lactation. J Steroid Biochem Mol Biol. 1991 Abstract
  29. World Health Organization (WHO) Task Force on Oral Contraceptives. Effects of hormonal contraceptives on breast milk composition and infant growth. Stud Fam Plann. 1988 Abstract
  30. Betrabet SS, Shikary ZK, Toddywalla VS, Toddywalla SP, Patel D, Saxena BN. ICMR Task Force Study on hormonal contraception. Transfer of norethisterone (NET) and levonorgestrel (LNG) from a single tablet into the infant's circulation through the mother's milk. Contraception. 1987 Abstract
  31. Betrabet SS, Shikary ZK, Toddywalla VS, Patel D, Vaidya P, Saxena BN. ICMR Task Force Study on hormonal contraception. Biological activity of ethinyl estradiol present in the breast milk. Contraception. 1986 Abstract
  32. Nilsson S, Mellbin T, Hofvander Y, Sundelin C, Valentin J, Nygren KG. Long-term follow-up of children breast-fed by mothers using oral contraceptives. Contraception. 1986 Abstract
  33. Madhavapeddi R, Ramachandran P. Side effects of oral contraceptive use in lactating women--enlargement of breast in a breast-fed child. Contraception. 1985 Abstract
  34. Tankeyoon M, Dusitsin N, Chalapati S, Koetsawang S, Saibiang S, Sas M, Gellen JJ, Ayeni O, Gray R, Pinol A, et al. Effects of hormonal contraceptives on milk volume and infant growth. WHO Special Programme of Research, Development and Research Training in Human Reproduction Task force on oral contraceptives. Contraception. 1984 Abstract
  35. Díaz S, Peralta O, Juez G, Herreros C, Casado ME, Salvatierra AM, Miranda P, Durán E, Croxatto HB. Fertility regulation in nursing women: III. Short-term influence of a low-dose combined oral contraceptive upon lactation and infant growth. Contraception. 1983 Abstract
  36. Croxatto HB, Díaz S, Peralta O, Juez G, Herreros C, Casado ME, Salvatierra AM, Miranda P, Durán E. Fertility regulation in nursing women: IV. Long-term influence of a low-dose combined oral contraceptive initiated at day 30 postpartum upon lactation and infant growth. Contraception. 1983 Abstract
  37. Peralta O, Díaz S, Juez G, Herreros C, Casado ME, Salvatierra AM, Miranda P, Durán E, Croxatto HB. Fertility regulation in nursing women: V. Long-term influence of a low-dose combined oral contraceptive initiated at day 90 postpartum upon lactation and infant growth. Contraception. 1983 Abstract
  38. Toddywalla VS, Mehta S, Virkar KD, Saxena BN. Release of 19-nor-testosterone type of contraceptive steroids through different drug delivery systems into serum and breast milk of lactating women. Contraception. 1980 Mar;21(3):217-23. Abstract
  39. Nilsson S, Nygren KG, Johansson ED. Ethinyl estradiol in human milk and plasma after oral administration. Contraception. 1978 Abstract
  40. Nilsson S, Nygren KG, Johansson ED. d-Norgestrel concentrations in maternal plasma, milk, and child plasma during administration of oral contraceptives to nursing women. Am J Obstet Gynecol. 1977 Abstract
  41. Saxena BN, Shrimanker K, Grudzinskas JG. Levels of contraceptive seroids in breast milk and plasma of lactating women. Contraception. 1977 Abstract
  42. Giner Velázquez J, Cortés Gallegos V, Sotelo López A, Bondani G. [Effect of daily oral administration of 0.350 mg of norethindrone on lactation and on the composition of milk]. Ginecol Obstet Mex. 1976 Abstract
  43. Guiloff E, Ibarra-Polo A, Zañartu J, Toscanini C, Mischler TW, Gómez-Rogers C. Effect of contraception on lactation. Am J Obstet Gynecol. 1974 Abstract
  44. Marriq P, Oddo G. [Letter: Gynecomastia in the newborn induced by maternal milk? An unusual complication of oral contraceptives]. Nouv Presse Med. 1974 Abstract
  45. Karim M, Ammar R, el-Mahgoub S, el-Ganzoury B, Fikri F, Abdou I. Injected progestogen and lactation. Br Med J. 1971 Abstract Full text (link to original source) Full text (in our servers)
  46. Balmer HC, Macdonald DJ. Hormonal therapy for suppressing lactation. Can Fam Physician. 1971 Abstract Full text (link to original source) Full text (in our servers)
  47. Kaern T. Effect of an oral contraceptive immediately post partum on initiation of lactation. Br Med J. 1967 Abstract Full text (link to original source) Full text (in our servers)
  48. CURTIS EM. ORAL-CONTRACEPTIVE FEMINIZATION OF A NORMAL MALE INFANT: REPORT OF A CASE. Obstet Gynecol. 1964 Abstract

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