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Progesterone use while Breastfeeding

Drugs containing Progesterone: Prometrium, Crinone, Endometrin, Menopause Formula Progesterone, Cyclogest, Gestone, Prochieve, Progest, First Progesterone MC5, Progestasert System, Show all 11 »First Progesterone MC10

Progesterone Levels and Effects while Breastfeeding

Summary of Use during Lactation

Release from the progesterone-releasing intrauterine device available in the United States is 65 mcg/day or only 0.65% of the dose released from most of the devices reported in the literature. Because of the low levels of progesterone in breastmilk, even with the high-dose products, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. The progesterone vaginal ring available in some countries produces maternal blood levels that are lower than those of ovulating women.[1] Most studies indicate that progesterone is not detrimental to milk production or duration of nursing.[2] No special precautions appear to be required.

Drug Levels

Maternal Levels. Women who received 6 subdermal implants containing 100 mg each of progesterone between days 30 to 35 postpartum for contraception had milk progesterone levels measured. Milk progesterone levels were 5.7 mcg/L in 6 women at 3 to 4 months postpartum and 6.3 mcg/L in 7 women at 9 to 12 months postpartum. By comparison, 9 women who received a Copper T intrauterine device had negligible progesterone levels. The authors estimated that infants would receive about 5 mcg of progesterone daily through breastmilk.[3][4]

Infant Levels. Women received 6 subdermal implants containing 100 mg each of progesterone between days 30 to 35 postpartum for contraception. A metabolite of progesterone, pregnane-3-glucuronide, was measured in the urine of their infants. At 3 to 4 months (n = 9) and 9 to 12 months (n = 7) postpartum, urine metabolite levels were 6.3 mcg/L and 15.7 mcg/L, respectively. These values were not significantly different from those of infants whose mothers were using a Copper T intrauterine device.[3][4]

Effects in Breastfed Infants

Eighty-four women had 6 subdermal implants containing 100 mg each of progesterone inserted between days 30 to 35 postpartum as a contraceptive. Compared to women who received either a placebo or a Copper T intrauterine device, there were no differences in the growth rates of their infants over the first 6 months postpartum.[5]

One hundred ninety-two mothers who received 6 subdermal implants containing 100 mg each of progesterone inserted on postpartum day 60 as a contraceptive. The weight gain of 60 infants who were exclusively breastfed for 6 months was compared to that of infants whose mothers received either placebo (n = 68 at day 30) or a Copper T (n = 64 at day 30 and n = 49 at day 60) intrauterine device. No differences were found in the average weight gains among the 3 groups of infants at 6 months of age.[6]

Vaginal rings that released progesterone were inserted at about 60 days postpartum in 128 women. The 2 types of rings released progesterone either 7.5 mg daily decreasing to 4.5 mg at 90 days or 15 mg daily decreasing to 7 mg daily at 90 days. Over the first 12 months postpartum, no differences in weight gain were found between the exclusively breastfed infants of mothers who received the progesterone rings and control mothers who received a Copper T intrauterine device for contraception.[7]

One hundred twenty breastfeeding women used a vaginal ring that released about 10 mg daily of progesterone for 90 days, starting during weeks 5 to 7 postpartum. No differences were found in the growth of breastfed infants or in developmental milestones compared to the normal population values.[8]

One hundred eighty-seven breastfeeding women used a vaginal ring that released about 10 mg daily of progesterone, starting at about day 57 postpartum. No differences were found in weight gain during the first 6 months of use compared to infants whose mothers received either a Copper T intrauterine device, an oral progestin-only contraceptive or levonorgestrel implant.[9]

A study comparing 100 women who received vaginal ring that released about 10 mg daily of progesterone to those who received a Copper T intrauterine device between days 29 and 64 postpartum found no differences in weight gain of their breastfed infants over the first year postpartum.[10]

Two hundred eighty-five women who received a vaginal ring that released about 10 mg daily of progesterone were compared to 262 women who received a Copper T intrauterine device beginning between weeks 5 and 9 postpartum. No differences in the weight gain of breastfed infants were seen between the 2 groups during the 14-month observation period.[11]

Effects on Lactation and Breastmilk

Eighty-four women had 6 subdermal implants containing 100 mg each of progesterone inserted between days 30 to 35 postpartum as a contraceptive. Compared to women who received either a placebo or a Copper T intrauterine device, no difference was found in the breastfeeding rates during the first 9 months postpartum. At 1 year postpartum, more women in the Copper T group were breastfeeding than in the progesterone or placebo groups.[5]

Vaginal rings that released progesterone were inserted at about 60 days postpartum in 246 women. The 3 types of rings released progesterone either 5, 10 or 15 mg daily. Control women received a Copper T intrauterine device. At 6 and 12 months postpartum there was no significant difference in the percentage of infants who were breastfed between the progesterone and Copper T groups.[12]

One hundred twenty breastfeeding women used a vaginal ring that released about 10 mg daily of progesterone, starting during weeks 5 to 7 postpartum. The rate of weaning was greater in the progesterone ring group than in groups of women who received levonorgestrel or norethindrone implants for postpartum contraception.[8]

In a multicenter study, 802 women who received a vaginal ring that released about 10 mg daily of progesterone were compared to 734 women who received a Copper T intrauterine device beginning at day 29 to 63 postpartum. No differences were found in the rate of breastfeeding between the 2 groups over the first year postpartum.[13]

Two hundred eighty-five women who received a vaginal ring that released about 10 mg daily of progesterone were compared to 262 women who received a Copper T intrauterine device beginning between weeks 5 and 9 postpartum. No differences in the breastfeeding rates were seen between the 2 groups during the 14-month observation period.[11]

An observational study followed 192 women who used a vaginal ring that released 10 mg of progesterone daily beginning between days 54 and 64 postpartum. All subjects used the vaginal ring for at least 4 months; 90% were still using it at 6 months and 73% were using it at 9 months postpartum. The duration of breastfeeding and infant growth were similar to reference groups.[14]

Alternate Drugs to Consider

(Contraception) Etonogestrel, Levonorgestrel, Medroxyprogesterone Acetate, Norethindrone

References

1. RamaRao S, Clark H, Merkatz R, Sussman H, Sitruk-Ware R. Progesterone vaginal ring: introducing a contraceptive to meet the needs of breastfeeding women. Contraception. 2013;88:591-8. PMID: 23769015

2. Carr SL, Gaffield ME, Dragoman MV, Philips S. Safety of the progesterone-releasing vaginal ring (PVR) among lactating women: A systematic review. Contraception. 2015. PMID: 25869631

3. Croxatto HB, Diaz S et al. Subdermal progesterone implants for fertility regulation in nursing women. In, Zatuchni GI, Goldsmith A, Shelton JD, Sciara JJ, eds. Long-acting contraceptive delivery systems. Philadelphia. Harper & Row. 1984.

4. Croxatto HB, Diaz S. The place of progesterone in human contraception. J Steroid Biochem. 1987;27: 991-4 . PMID: 3320572

5. Croxatto HB, Diaz S et al. Fertility regulation in nursing women. II. Comparative performance of progesterone implants versus placebo and copper T. Am J Obstet Gynecol. 1982;144:201-8. PMID: 7114130

6. Diaz S, Peralta O et al. Fertility regulation in nursing women. VI. Contraceptive effectiveness of a subdermal progesterone implant. Contraception. 1984;30:311-25. PMID: 6509984

7. Diaz S, Jackanicz TM et al. Fertility regulation in nursing women: VIII. Progesterone plasma levels and contraceptive efficacy of a progesterone-releasing vaginal ring. Contraception. 1985;32:603-22. PMID: 3912105

8. Shaaban MM. Contraception with progestogens and progesterone during lactation. J Steroid Biochem Mol Biol. 1991;40:705-10. PMID: 1835650

9. Diaz S, Zepeda A et al. Fertility regulation in nursing women IX. Contraceptive performance, duration of lactation, infant gowth, and bleeding patterns during use of progesterone vaginal rings, progestin-only pills, Norplant implants, and Copper T 380-A intrauterine devices. Contraception. 1997;56:223-32. PMID: 9408703

10. Chen JH, Wu SC et al. The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women. Contraception. 1998;57:371-9. PMID: 9693396

11. Massai R, Miranda P et al. Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women. Contraception. 1999;60:9-14. PMID: 10549447

12. Croxatto HB, Diaz S. Progesterone vaginal rings for contraception during breastfeeding. In, Runnebaum R, Rabe T, Kiesel L, eds. Advances in gynecological and obstetric research series. Vol. 2. Female contraception and male fertility regulation. New Jersey. Parthenon. 1987;2:135-42.

13. Sivin I, Diaz S et al. Contraceptives for lactating women: a comparative trial of a progesterone-releasing vaginal ring and the copper T 380A IUD. Contraception. 1997;55:225-32. PMID: 9179454

14. Massai R, Quinteros E, Reyes MV et al. Extended use of a progesterone-releasing vaginal ring in nursing women: a phase II clinical trial. Contraception. 2005;72:352-7. PMID: 16246661

Progesterone Identification

Substance Name

Progesterone

CAS Registry Number

57-83-0

Drug Class

Hormones

Progesterone Congeners

Administrative Information

LactMed Record Number

470

Last Revision Date

20150505

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