Last update July 16, 2017

Estradiol + Nomegestrol

Low Risk

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

Combined contraceptive with Estrogen (Estradiol hemihydrate) plus Progestin (Nomegestrol acetate) for daily oral administration.

ESTRADIOL is excreted in breast milk in clinically non-significant amount without problems having been observed in infants whose mothers have received it. Plasma levels of drug in those infants were undetectable or very low. There was higher excretion into milk when administered vaginally.
There is some evidence (though not definite) that estrogens may decrease milk production, especially if they are used during the first few days postpartum.
Estrogens may decrease the protein content of breastmilk.
No problems have been observed in infants whose mothers were on estrogens, except for rare cases of transient gynecomastia in infants whose mothers received higher doses than usual.
Exposure to estrogen in childhood or adolescence does not influence subsequent milk production.

NOMEGESTROL is a third generation synthetic progestogen which is structurally related to progesterone.
It has been used as a part of only-one-component contraceptives which have one year lasting effect in subdermal implants. Also orally used alone or associated to estrogen (see info on Estradiol + Nomegestrol).

In a study comparing effects on breastfeeding women (120 with a Nomegestrol implant and 120 with an intrauterine device (IUD), there were no significant differences on duration of breastfeeding nor somatic follow-up criteria nor health issues in infants (Abdel -Aleem 1996).

Differences on frequency of breastfeeding, amount of milk production and the weight gain of breastfed infants with similar combined contraceptives compared to other contraceptive methods (intrauterine devices, isolated progestogens) have not been observed. However, it would advisable to avoid them until breastfeeding is well established (4 to 6 weeks).

During lactation, progestogen-only contraceptives are preferred over those combined with estrogen. Otherwise, those with lower doses of estrogen should be used.
Within the first 6 weeks postpartum, non-hormonal contraceptive methods should be the first option.

Hormonal contraceptives do not change the milk composition whether minerals (Mg, Fe, Cu, Ca, P), fats, lactose or calories but a little protein.


See below the information of these related products:

  • Estradiol (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Nomegestrol Acetate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Alternatives

We do not have alternatives for Estradiol + Nomegestrol.

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

Estradiol + Nomegestrol in other languages or writings:

Group

Estradiol + Nomegestrol belongs to this group or family:

Tradenames

Main tradenames from several countries containing Estradiol + Nomegestrol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 5 / 63 %
Molecular weight 272 / 371 daltons
Protein Binding 98 / 98 %
VD - / 1.7 l/Kg
Tmax 1 - 4 / 2 hours
20 - 26 / 46 (28 - 83) hours

References

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  2. 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)
  3. Reisman T, Goldstein Z. Case Report: Induced Lactation in a Transgender Woman. Transgend Health. 2018 Jan 1;3(1):24-26. Abstract Full text (link to original source) Full text (in our servers)
  4. EMA. Estradiol + Nomegestrol acetato. Ficha técnica. 2016 Full text (in our servers)
  5. 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)
  6. EMA. Estradiol + Nomegestrol acetate. Drug Summary. 2016 Full text (in our servers)
  7. 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
  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. 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)
  10. Pinheiro E, Bogen DL, Hoxha D, Wisner KL. Transdermal estradiol treatment during breastfeeding: maternal and infant serum concentrations. Arch Womens Ment Health. 2015 Abstract Full text (link to original source) Full text (in our servers)
  11. 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)
  12. 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)
  13. 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)
  14. Tepper NK, Phillips SJ, Kapp N, Gaffield ME, Curtis KM. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2015 Abstract
  15. 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
  16. 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)
  17. Dutta DK, Dutta I. Desogestrel mini pill: is this safe in lactating mother? J Indian Med Assoc. 2013 Abstract
  18. 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)
  19. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  20. Urzica D, Gales C, Zamfir C, Nechifor M. The influence of oral steroidal contraceptives on magnesium concentration in breast milk. Magnes Res. 2013 Abstract
  21. 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)
  22. 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
  23. 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)
  24. Shaamash AH, Sayed GH, Hussien MM, Shaaban MM. A comparative study of the levonorgestrel-releasing intrauterine system Mirena versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development. Contraception. 2005 Abstract
  25. Perheentupa A, Ruokonen A, Tapanainen JS. Transdermal estradiol treatment suppresses serum gonadotropins during lactation without transfer into breast milk. Fertil Steril. 2004 Abstract
  26. 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
  27. 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)
  28. 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)
  29. Bjarnadóttir RI, Gottfredsdóttir H, Sigurdardóttir K, Geirsson RT, Dieben TO. Comparative study of the effects of a progestogen-only pill containing desogestrel and an intrauterine contraceptive device in lactating women. BJOG. 2001 Abstract
  30. 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)
  31. Dórea JG. Oral contraceptives do not affect magnesium in breast milk. Int J Gynaecol Obstet. 2000 Abstract
  32. Dorea JG, Miazaki ES. The effects of oral contraceptive use on iron and copper concentrations in breast milk. Fertil Steril. 1999 Abstract
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  35. Abdel-Aleem H, Abol-Oyoun el-S M, Shaaban MM, el-Saeed M, Shoukry M, Makhlouf A, Salem HT. The use of nomegestrol acetate subdermal contraceptive implant, uniplant, during lactation. Contraception. 1996 Abstract
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  40. 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
  41. Madhavapeddi R, Ramachandran P. Side effects of oral contraceptive use in lactating women--enlargement of breast in a breast-fed child. Contraception. 1985 Abstract
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  43. 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
  44. 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
  45. 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
  46. Nilsson S, Nygren KG, Johansson ED. Transfer of estradiol to human milk. Am J Obstet Gynecol. 1978 Abstract
  47. 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
  48. 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
  49. Marriq P, Oddo G. [Letter: Gynecomastia in the newborn induced by maternal milk? An unusual complication of oral contraceptives]. Nouv Presse Med. 1974 Abstract
  50. 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)
  51. 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)
  52. CURTIS EM. ORAL-CONTRACEPTIVE FEMINIZATION OF A NORMAL MALE INFANT: REPORT OF A CASE. Obstet Gynecol. 1964 Abstract

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