Free Standard AU & NZ Shipping For All Book Orders Over $80!
Register      Login
Sexual Health Sexual Health Society
Publishing on sexual health from the widest perspective
RESEARCH ARTICLE

Oestradiol implants for gender-affirming hormone therapy: an observational study of serum oestradiol levels and consumer survey

Joanna Mesure https://orcid.org/0000-0001-7833-8237 A * , Sarjana Afrin B , Sandra Fitzgerald C , Judy Luu D E , Alison Gibberd F , Lucy Leigh F and Katie Wynne D E G
+ Author Affiliations
- Author Affiliations

A HNE Sexual Health, Newcastle, NSW, Australia.

B Department of Medicine, John Hunter Hospital, Newcastle, NSW, Australia.

C Primary Health Network, Hunter New England and Central Coast, Newcastle, NSW, Australia.

D Department of Diabetes & Endocrinology, John Hunter Hospital, Newcastle, NSW, Australia.

E School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.

F Hunter Medical Research Institute, Newcastle, NSW, Australia.

G Equity in Health and Wellbeing Program, Hunter Medical Research Institute, Newcastle, NSW, Australia.

* Correspondence to: joanna.mesure@health.nsw.gov.au

Handling Editor: Darren Russell

Sexual Health 20(6) 550-557 https://doi.org/10.1071/SH23126
Submitted: 11 July 2023  Accepted: 27 September 2023  Published: 17 October 2023

© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing

Abstract

Background

Custom-compounded subcutaneous implants are being used widely in Australia for gender-affirming hormone therapy. However, there is no published literature regarding their use for this purpose.

Methods

Electronic medical records were audited for consecutive clients who received oestradiol implants April 2019–November 2022 in gender clinics held within Hunter New England Health District in New South Wales, Australia. Serum oestradiol levels were analysed for implant doses 50–200 mg, and predicted oestradiol level was modelled following 100 mg implant insertion. An electronic consumer survey was sent to a convenience sample of implant recipients.

Results

A total of 38 clients received 88 implants, with 100 mg oestradiol implants being the most frequently used (68%). The median interval between insertion procedures was 270 (IQR 186–399) days. The median serum oestradiol levels following implant insertion, for all implants combined, were within the target range of 250–600 pmol/L at 1-, 3-, 6-, 9- and 12-month time points. Following insertion of a 100 mg implant, the estimated time to reach a predicted serum oestradiol of ≤250 pmol/L was 4 months after an initial implant, and 13 months after subsequent implants. Seventeen consumer surveys were received from 28 invitations. All respondents had previous experience of oral and/or transdermal oestradiol use. Oestradiol implants were preferred due to ease of use, perceived effectiveness, and the belief that other methods were less safe or associated with intolerance and side effects.

Conclusions

Oestradiol implants are effective in achieving target serum oestradiol levels over a sustained period. Further research with larger cohorts could identify the optimal dosage regimen.

Keywords: compounding, gender affirmation, gender-affirming hormone therapy, gender dysphoria, hormone therapy, oestradiol levels, subcutaneous implants, transgender.

References

Cundill P. Hormone therapy for trans and gender diverse patients in the general practice setting. Aust J Gen Pract 2020; 49(7): 385-390.
| Crossref | Google Scholar | PubMed |

Bretherton I, Thrower E, Grossmann M, Zajac JD, Cheung AS. Cross-sex hormone therapy in Australia: the prescription patterns of clinicians experienced in adult transgender healthcare. Intern Med J 2019; 49(2): 182-188.
| Crossref | Google Scholar | PubMed |

AusPATH. Australian informed consent standards of care for gender affirming hormone therapy. Australian Professional Association for Trans Health; 2022. Available at https://auspath.org.au/2022/03/31/auspath-australian-informed-consent-standards-of-care-for-gender-affirming-hormone-therapy/

Cocchetti C, Romani A, Collet S, Greenman Y, Schreiner T, Wiepjes C, et al. The ENIGI (European Network for the Investigation of Gender Incongruence) study: overview of acquired endocrine knowledge and future perspectives. J Clin Med 2022; 11(7): 1784.
| Crossref | Google Scholar | PubMed |

Shatzel JJ, Connelly KJ, DeLoughery TG. Thrombotic issues in transgender medicine: a review. Am J Hematol 2017; 92(2): 204-208.
| Crossref | Google Scholar | PubMed |

Templeman C, Quinn D, Hansen R, Moreton T, Baber R. An audit of oestrogen implant hormone replacement therapy. Aust N Z J Obstet Gynaecol 1998; 38(4): 455-460.
| Crossref | Google Scholar | PubMed |

Suhonen SP, Allonen HO, Lähteenmäki P. Sustained-release subdermal estradiol implants: a new alternative in estrogen replacement therapy. Am J Obstet Gynecol 1993; 169(5): 1248-1254.
| Crossref | Google Scholar | PubMed |

Studd J, Magos A. Hormone pellet implantation for the menopause and premenstrual syndrome. Obstet Gynecol Clin North Am 1987; 14(1): 229-249.
| Crossref | Google Scholar | PubMed |

Studd JWW, Smith RN. Oestradiol and testosterone implants. Baillieres Clin Endocrinol Metab 1993; 7(1): 203-223.
| Crossref | Google Scholar | PubMed |

10  Notelovitz M, Johnston M, Smith S, Kitchens C. Metabolic and hormonal effects of 25-mg and 50-mg 17 beta-estradiol implants in surgically menopausal women. Obstet Gynecol 1987; 70(5): 749-754.
| Google Scholar | PubMed |

11  Kapetanakis E, Dmowski WP, Auletta F, Scommegna A. Endocrine and clinical effects of estradiol and testosterone pellets used in long-term replacement therapy. Int J Gynaecol Obstet 1982; 20(5): 387-399.
| Crossref | Google Scholar | PubMed |

12  Donovitz GS. Low complication rates of testosterone and estradiol implants for androgen and estrogen replacement therapy in over 1 million procedures. Ther Adv Endocrinol Metab 2021; 12: 204201882110152.
| Crossref | Google Scholar |

13  Baker VL. Alternatives to oral estrogen replacement. Transdermal patches, percutaneous gels, vaginal creams and rings, implants, other methods of delivery. Obstet Gynecol Clin North Am 1994; 21(2): 271-297.
| Crossref | Google Scholar | PubMed |

14  Dixit A, Carden N, Stephens E, Chadwick M, Tamblyn J, Robinson L. Hormone replacement therapy subcutaneous implants for refractory menopause symptoms; the patient’s perspective. Post Reproductive Health 2022; 28(2): 79-91.
| Crossref | Google Scholar | PubMed |

15  Wheatley S, Bell RJ, Stuckey BGA, Robinson PJ, Davis SR. Clinical audit of estradiol implant therapy: long duration of action and implications in non-hysterectomised women. Maturitas 2016; 94: 84-86.
| Crossref | Google Scholar | PubMed |

16  Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric 2005; 8(sup1): 3-63.
| Crossref | Google Scholar |

17  Cravioto Mdc, Larrea F, Delgado NE, Escobar AR, Díaz-Sánchez V, Domínguez J, et al. Pharmacokinetics and pharmacodynamics of 25-mg estradiol implants in postmenopausal Mexican women. Menopause 2001; 8(5): 353-360.
| Crossref | Google Scholar | PubMed |

18  Buckler HM, Kalsl PK, Cantrill JA, Anderson DC. An audit of oestradiol levels and implant frequency in women undergoing subcutaneous implant therapy. Clin Endocrinol 1995; 42(5): 445-450.
| Crossref | Google Scholar |

19  Joshi H, Gezer E, Espina M, Seal L. Efficacy of oestrogen implant in transwomen as hormone replacement therapy. Poster presented at Society for Endocrinology BES 2021; Edinburgh, United Kingdom. Endocrine Abstracts (2021) 77 LB27. doi:10.1530/endoabs.77.LB27

20  Australian Government. Therapeutic Goods Act 1989. 2023. Available at https://www.legislation.gov.au/Details/C2023C00102 [accessed 11 July 2023]

21  Femcare. Trocar Cannula Obturator. 2021. Available at https://www.rociallehealthcare.com/wp-content/uploads/2021/10/RT01-047_IFU_for_TROCAR_CANNULA_OBTURATOR.pdf [accessed 11 July 2023]

22  ACON. Feminising hormones. 2021. Available at https://www.transhub.org.au/clinicians/feminising-hormones [accessed 11 July 2023]

23  Cheung AS, Wynne K, Erasmus J, Murray S, Zajac JD. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211(3): 127-133.
| Crossref | Google Scholar | PubMed |

24  Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, et al. Endocrine treatment of gender-dysphoric/gender-incongruent persons: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2017; 102(11): 3869-3903.
| Crossref | Google Scholar | PubMed |

25  von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008; 61(4): 344-349.
| Crossref | Google Scholar | PubMed |

26  R Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2022. Available at https://www.R-project.org [accessed 11 July 2023]

27  Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42(2): 377-381.
| Crossref | Google Scholar | PubMed |

28  Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform 2019; 95: 103208.
| Crossref | Google Scholar | PubMed |

29  Faubion SS, Crandall CJ, Davis L, El Khoudary SR, Hodis HN, Lobo RA, Maki PM, Manson JE, Pinkerton JV, Santoro NF, Shifren JL, Shufelt CL, Thurston RC, Wolfman W. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause 2022; 29(7): 767-794.
| Crossref | Google Scholar | PubMed |

30  LaVasseur C, Neukam S, Kartika T, Samuelson Bannow B, Shatzel J, DeLoughery TG. Hormonal therapies and venous thrombosis: considerations for prevention and management. Res Pract Thromb Haemost 2022; 6(6): e12763.
| Crossref | Google Scholar | PubMed |