Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Oestradiol

Generic name
Oestradiol
Brand name
ATC Code
G03CA03

Pharmacokinetics in children

No information on PK parameters in children available.

In adults, after oral administration, a Cmax of approx. 30 pg/ml is reached within 4 to 8 hours. The bioavailability after transdermal administration via a patch is about 20 times higher than after oral administration. In studies conducted on postmenopausal women who applied estradiol patches containing 25, 37.5, 50 and 100 µg/24 hours, the Cmax values were approx. 25 pg/ml, 35 pg/ml, 50-55 pg/ml and 95-105 pg/ml, respectively. The volume of distribution in adults is 1.2 l/kg, and the elimination half-life is approximately 24 hours. After discontinuation of oral administration, normal estradiol and estrone plasma concentrations are restored within 3-4 days. Within 24 hours after patch removal, plasma concentrations return to baseline [SmPC Progynova] [SmPC Sandoz] [SmPC Systen].

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Priming before a growth hormone test
  • Oral
    • ≥ 8 years and ≥ 20 kg
      [3]
      • 2 mg/day in 1 dose
      • Duration of treatment:

        Administer in the evening during 3 days prior to the test

      • Directions for administration:

        Administer in the evening

    • ≥ 8 years and < 20 kg
      [3]
      • 1 mg/day in 1 dose
      • Duration of treatment:

        Administer in the evening during 3 days prior to the test

      • Directions for administration:

        Administer in the evening

    • Girls ≥ 8 years and < 20 kg or boys ≥ 11 years and ≥ 20 kg
      • 2 mg/day in 1 dose
      • Duration of treatment:

        Administer in the evening during 3 days prior to the test

      • Directions for administration:

        Administer in the evening

    • Girls ≥ 8 years and < 20 kg or boys ≥ 11 years and < 20 kg
      • 1 mg/day in 1 dose
      • Duration of treatment:

        Administer in the evening during 3 days prior to the test

      • Directions for administration:

        Administer in the evening
Puberty induction in pubertas tarda: hypogonadism
  • Transdermal
    • Girls ≥ 11 years
      •   < 40 kg > 40-55 kg > 55 kg
        Year 1 3,1 microg 4,2 microg 6,2 microg
        Year 2 6,2 microg 8,3 microg 12,5 microg
          < 50 kg 50-65 kg ≥ 65 kg
        Year 3 16,7 microg 18,8 microg 25 microg
        Year 4 and onwards 1 microg/kg/day 1 microg/kg/day 1 microg/kg/day
           Patch 25 microg Patch 37,5 microg Patch 50 microg
        3,1 microg 1/8e of patch 1/12 of patch 1/16e of patch
        4,2 microg 1/6e of patch 1/9 of patch 1/12e of patch
        6,2 microg 1/4e of patch 1/6 of patch 1/8e of patch
        8,3 microg 1/3e of patch 2/9 of patch 1/6e of patch
        12,5 microg 1/2e of patch 1/3 of patch 1/4e of patch
        16,7 microg 2/3e of patch 4/9 of patch 1/3e of patch
        18,8 microg 3/4e of patch 1/2 patch 3/8e of patch
        25 microg 1 patch 2/3 of patch 1/2 patch

         

        • Year 1 and 2: Apply before going to bed. Remove in the morning after
        • Year 3: Cut the desired dose into two halves; attach both parts to the skin in the evening. After 10–12 h (overnight) remove one part, keep the second part during the day. Remove the second part in the evening, before evening application of a new pair of patches.
        • Year 4: Patch continuously attached to the skin. Apply whole patch 3 times weekly, that is, changing after 2–3 days.
        • At start of year 4: Serum sample for estradiol target to be drawn in the morning after the previous evening’s dose, target range 150–450 pmol/L.
  • Oral
    • Girls ≥ 11 years
      • Initial dose during first year (0-12 months):  5 microg./kg/day in 1 dose
      • Directions for administration:

        Administer before going to bed

      • Afterwards:

          Standard schedule Adjusted schedule
        In older age or clinical signs (e.g. breast development, increased growth velocity) support more rapid pubertal progression
        13 - 24 months 5 microg./kg/day 7,5 microg./kg/day
        25 - 30 months 7,5 microg./kg/day 10 microg./kg/day
        31 - 36 months 10 microg./kg/day 15 microg./kg/day
        37 - 42 months 15 microg./kg/day 20 microg./kg/day
        43 - 48 months 20 microg./kg/day Further titration up to the adult dose
        (2 mg/day)
        ≥49 months Further titration up to the adult dose (2 mg/day)  
        • Adjusted titration according to individual needs 

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Patch: mild skin reactions [Cisternino 1991].                                                                        

Oral: moderate transient breast enlargement when using estradiol for priming [Martínez 2000].

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Natural and semisynthetic estrogens, plain
G03CA01
G03CA04
G03CA57
NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN
G03CA01
G03CA04
G03CA57

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
  3. NVK werkgroep Groeihormoon, Protocol voor priming met geslachtshormonen voorafgaande aan groeihormoon stimulatietesten, 13 dec 2019
  4. Donaldson M et al, Optimal Pubertal Induction in Girls with Turner Syndrome Using Either Oral or Transdermal Estradiol: A Proposed Modern Strategy, Horm Res Paediatr, 2019, 91, 1-11
  5. Ankarberg-Lindgren, C et al, Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures, Endocrine Connections, 2019, 8, 360-366
  6. Sas, T et al, Pubertas Tarda -Diagnostiek en behandeling, www.nvk.nl (access restricted to members), May, 17, 2016
  7. Nederlandse Vereniging voor Kindergeneeskunde, Sectie Kinderendocrinologie., Overzicht behandelmogelijkheden inductie van puberteit en pubertas tarda., February 2025
  8. Bayer BV, SmPC Progynova 1 en 2 mg (RVG 05861/05311) 30 January 2024, www.geneesmiddelinformatiebank.nl
  9. Sandoz B.V., SmPC Estradiol Sandoz pleister (RVG 19581/19582) 8 February 2024, www.geneesmiddelinformatiebank.nl
  10. Theramex Ireland Limited., SmPC Systen (RVG 16080/ 19258/19259) 8 January 2024, www.geneesmiddelinformatiebank.nl
  11. Cisternino M. et al, Transdermal estradiol substitution therapy for the induction of puberty in female hypogonadism., J Endocrinol Invest., 1991, Jun;14(6), 481-8
  12. Bannink EM, et al., Puberty induction in Turner syndrome: results of oestrogen treatment on development of secondary sexual characteristics, uterine dimensions and serum hormone levels., Clin Endocrinol (Oxf)., 2009, Feb;70(2), 265-73
  13. van Pareren YK, et al., Final height in girls with turner syndrome after long-term growth hormone treatment in three dosages and low dose estrogens., J Clin Endocrinol Metab., 2003, Mar;88(3), 1119-25
  14. Molina S, et al., Is testosterone and estrogen priming prior to clonidine useful in the evaluation of the growth hormone status of short peripubertal children?, J Pediatr Endocrinol Metab, 2008, Mar;21(3), 257-6
  15. Martínez AS et al., Estrogen priming effect on growth hormone (GH) provocative test: a useful tool for the diagnosis of GH deficiency., J Clin Endocrinol Metab, 2000, Nov;85(11), 4168-72
  16. Ankarberg-Lindgren C, et al., Physiological estrogen replacement therapy for puberty induction in girls: a clinical observational study., Horm Res Paediatr., 2014, 81(4), 239-44
  17. Ankarberg-Lindgren C, et al., Nocturnal application of transdermal estradiol patches produces levels of estradiol that mimic those seen at the onset of spontaneous puberty in girls., J Clin Endocrinol Metab., 2001, Jul;86(7), 3039-44

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Changes

Changes