Last update April 8, 2022

Эстрадиол + Диеногест

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)

ESTRADIOL is excreted into breast milk in clinically insignificant (Nilson 1978) or null amounts (Pinheiro 2016, Perheentupa 2004) and no problems have been observed in infants whose mothers were treated. (Reisman 2018, Pinheiro 2016)

Plasma levels of these infants were undetectable or very low. (Pinheiro 2016)

After administration in the form of transdermal patches milk levels have been undetectable. (Pinheiro 2016, Perheentupa 2004)

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)

DIENOGEST is a progestin with a similar structure as levonorgestrel.

A latest update no published data on excretion into breast milk were found.

Progesterone and other related progestin drugs are excreted into breast milk in clinically non-significant amount (Croxatto 1987, Betrabet 1987, Nilsson 1977) and no problems have been observed in infants whose mothers were treated with this medication. (Roy 2020, Bahamondes 2013, Dutta 2013, Shaamash 2005, Bjarnadóttir 2001, Díaz 1997)


See below the information of these related products:

  • (Contraceptive combined Estrogen & Progestins) (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Dienogest (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Estradiol (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

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

Эстрадиол + Диеногест is Estradiol + Dienogest in Cyrillic.

Is written in other languages:

Group

Эстрадиол + Диеногест belongs to this group or family:

Tradenames

Main tradenames from several countries containing Эстрадиол + Диеногест in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 5 / 91 %
Molecular weight 272 / 311 daltons
Protein Binding 98 / 90 %
VD - / 0.55 l/Kg
Tmax 1 - 4 / 1.5 hours
20 - 26 / 10 - 14 hours
M/P ratio 0.1 -

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. Roy M, Hazra A, Merkatz R, Plagianos M, Alami M, Gaur LN, Aruldas K, Sussman H, Variano B, Sitruk-Ware R; Progesterone Vaginal Ring Study Group at Participating Centers.. Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India. Contraception. 2020 Sep;102(3):159-167. 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. 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)
  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. 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)
  8. Tepper NK, Phillips SJ, Kapp N, Gaffield ME, Curtis KM. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2015 Abstract
  9. 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)
  10. 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
  11. 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)
  12. 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)
  13. 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)
  14. Dutta DK, Dutta I. Desogestrel mini pill: is this safe in lactating mother? J Indian Med Assoc. 2013 Abstract
  15. 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)
  16. 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
  17. Urzica D, Gales C, Zamfir C, Nechifor M. The influence of oral steroidal contraceptives on magnesium concentration in breast milk. Magnes Res. 2013 Abstract
  18. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  19. 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
  20. 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)
  21. 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)
  22. 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
  23. Perheentupa A, Ruokonen A, Tapanainen JS. Transdermal estradiol treatment suppresses serum gonadotropins during lactation without transfer into breast milk. Fertil Steril. 2004 Abstract
  24. 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
  25. 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)
  26. 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)
  27. 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
  28. Dórea JG. Oral contraceptives do not affect magnesium in breast milk. Int J Gynaecol Obstet. 2000 Abstract
  29. 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)
  30. Dorea JG, Miazaki ES. The effects of oral contraceptive use on iron and copper concentrations in breast milk. Fertil Steril. 1999 Abstract
  31. Dorea JG, Myazaki E. Calcium and phosphorus in milk of Brazilian mothers using oral contraceptives. J Am Coll Nutr. 1998 Abstract
  32. Díaz S, Zepeda A, Maturana X, Reyes MV, Miranda P, Casado ME, Peralta O, Croxatto HB. Fertility regulation in nursing women. IX. Contraceptive performance, duration of lactation, infant growth, and bleeding patterns during use of progesterone vaginal rings, progestin-only pills, Norplant implants, and Copper T 380-A intrauterine devices. Contraception. 1997 Abstract
  33. Costa TH, Dorea JG. Concentration of fat, protein, lactose and energy in milk of mothers using hormonal contraceptives. Ann Trop Paediatr. 1992 Abstract
  34. 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
  35. 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
  36. Croxatto HB, Díaz S. The place of progesterone in human contraception. J Steroid Biochem. 1987;27(4-6):991-4. Review. Abstract
  37. 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
  38. Madhavapeddi R, Ramachandran P. Side effects of oral contraceptive use in lactating women--enlargement of breast in a breast-fed child. Contraception. 1985 Abstract
  39. 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
  40. 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
  41. 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
  42. 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
  43. Nilsson S, Nygren KG, Johansson ED. Transfer of estradiol to human milk. Am J Obstet Gynecol. 1978 Abstract
  44. 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
  45. 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
  46. Marriq P, Oddo G. [Letter: Gynecomastia in the newborn induced by maternal milk? An unusual complication of oral contraceptives]. Nouv Presse Med. 1974 Abstract
  47. 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)
  48. 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)
  49. CURTIS EM. ORAL-CONTRACEPTIVE FEMINIZATION OF A NORMAL MALE INFANT: REPORT OF A CASE. Obstet Gynecol. 1964 Abstract

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