Addition of progesterone to feminizing gender-affirming hormone therapy in transgender individuals for breast development: a randomized controlled trial.

Breast development Breast volume Estradiol Gender-affirming hormone therapy Progesterone Transgender

Journal

BMC pharmacology & toxicology
ISSN: 2050-6511
Titre abrégé: BMC Pharmacol Toxicol
Pays: England
ID NLM: 101590449

Informations de publication

Date de publication:
20 Dec 2023
Historique:
received: 15 03 2023
accepted: 12 12 2023
medline: 21 12 2023
pubmed: 21 12 2023
entrez: 21 12 2023
Statut: epublish

Résumé

Feminizing gender-affirming hormone therapy (GAHT) for transgender individuals traditionally includes estradiol and androgen deprivation. Research has demonstrated that breast size as a result of GAHT in transgender women is often limited. Therefore, transgender women often choose to undergo breast augmentation surgery. Progesterone is important for breast development in cisgender women during puberty. A potential role for progesterone in breast development in transgender women has not been investigated in a randomized controlled experimental set-up. The primary objective of this study is to explore the effects on breast volume of addition of oral progesterone to GAHT with estradiol in transgender women after vaginoplasty or orchiectomy. Secondary objectives include assessment of safety, satisfaction, mood, sleep and sexual pleasure. This is a non-blinded, non-placebo, randomized controlled trial using a factorial design in adult transgender individuals assigned male sex at birth who have undergone GAHT for at least one year and underwent vaginoplasty or orchiectomy. The study design allows for rapid assessment of potential synergistic effects of various dose combinations of estradiol and progesterone on breast volume change: Ninety participants will be randomized into six groups of 15 subjects each, receiving either the baseline dose of estradiol, the baseline dose of estradiol and progesterone 200 mg daily, the baseline dose of estradiol and progesterone 400 mg daily, twice the baseline dose of estradiol, twice the baseline dose of estradiol and progesterone 200 mg daily or twice the baseline dose of estradiol and progesterone 400 mg daily, all for a duration of 12 months. The main study parameters include changes in breast volume as determined by 3D measurements. Participants will be followed-up with laboratory testing including serum progesterone concentrations as well as surveys for satisfaction, mood, sleep quality and sexual pleasure. This study will indicate whether progesterone is safe and of additional value with regard to breast volume change in transgender individuals receiving feminizing GAHT. The results of this study will be useful for innovation of feminizing GAHT. WHO International Clinical Trials Registry Platform: EUCTR2020-001952-16-NL; date of registration: 12 December 2020 https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-001952-16-NL .

Sections du résumé

BACKGROUND BACKGROUND
Feminizing gender-affirming hormone therapy (GAHT) for transgender individuals traditionally includes estradiol and androgen deprivation. Research has demonstrated that breast size as a result of GAHT in transgender women is often limited. Therefore, transgender women often choose to undergo breast augmentation surgery. Progesterone is important for breast development in cisgender women during puberty. A potential role for progesterone in breast development in transgender women has not been investigated in a randomized controlled experimental set-up. The primary objective of this study is to explore the effects on breast volume of addition of oral progesterone to GAHT with estradiol in transgender women after vaginoplasty or orchiectomy. Secondary objectives include assessment of safety, satisfaction, mood, sleep and sexual pleasure.
METHODS METHODS
This is a non-blinded, non-placebo, randomized controlled trial using a factorial design in adult transgender individuals assigned male sex at birth who have undergone GAHT for at least one year and underwent vaginoplasty or orchiectomy. The study design allows for rapid assessment of potential synergistic effects of various dose combinations of estradiol and progesterone on breast volume change: Ninety participants will be randomized into six groups of 15 subjects each, receiving either the baseline dose of estradiol, the baseline dose of estradiol and progesterone 200 mg daily, the baseline dose of estradiol and progesterone 400 mg daily, twice the baseline dose of estradiol, twice the baseline dose of estradiol and progesterone 200 mg daily or twice the baseline dose of estradiol and progesterone 400 mg daily, all for a duration of 12 months. The main study parameters include changes in breast volume as determined by 3D measurements. Participants will be followed-up with laboratory testing including serum progesterone concentrations as well as surveys for satisfaction, mood, sleep quality and sexual pleasure.
DISCUSSION CONCLUSIONS
This study will indicate whether progesterone is safe and of additional value with regard to breast volume change in transgender individuals receiving feminizing GAHT. The results of this study will be useful for innovation of feminizing GAHT.
TRIAL REGISTRATION BACKGROUND
WHO International Clinical Trials Registry Platform: EUCTR2020-001952-16-NL; date of registration: 12 December 2020 https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-001952-16-NL .

Identifiants

DOI: 10.1186/s40360-023-00724-4 PMID: 38124194
pubmed: 38124194
doi: 10.1186/s40360-023-00724-4
pii: 10.1186/s40360-023-00724-4
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

80

Informations de copyright

© 2023. The Author(s).

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Auteurs

Benthe A M Dijkman (BAM)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Danithsia Helder (D)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Lidewij S Boogers (LS)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Noor C Gieles (NC)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Jason O van Heesewijk (JO)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Sjoerd Te Slaa (ST)

Department of Medical Technology, 3D Innovation Lab, Amsterdam UMC, location VU University, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.

Niels P T J Liberton (NPTJ)

Department of Medical Technology, 3D Innovation Lab, Amsterdam UMC, location VU University, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.

Chantal M Wiepjes (CM)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Christel J M de Blok (CJM)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Martin den Heijer (M)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Koen M A Dreijerink (KMA)

Department of Endocrinology and Metabolism, Center of Expertise on Gender Dysphoria, Endo-ERN Reference Center; Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. k.dreijerink@amsterdamumc.nl.
Research Institute Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, location VU University, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. k.dreijerink@amsterdamumc.nl.

Classifications MeSH