Evidence map›Paper›PMID 38124194›Full record

Trial reportBMC pharmacology & toxicology2023

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

Benthe A M Dijkman, Danithsia Helder, Lidewij S Boogers, Noor C Gieles, Jason O van Heesewijk, Sjoerd Te Slaa, Niels P T J Liberton, Chantal M Wiepjes, Christel J M de Blok, Martin den Heijer and 1 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pharmacology & toxicology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Guideline
  2. Article
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Benthe A M DijkmanDepartment 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.
Danithsia HelderDepartment 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.
Lidewij S BoogersDepartment 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.
Noor C GielesDepartment 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.
Jason O van HeesewijkDepartment 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.
Sjoerd Te SlaaDepartment of Medical Technology, 3D Innovation Lab, Amsterdam UMC, location VU University, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
Niels P T J LibertonDepartment of Medical Technology, 3D Innovation Lab, Amsterdam UMC, location VU University, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
Chantal M WiepjesDepartment 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.
Christel J M de BlokDepartment 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.
Martin den HeijerDepartment 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.
Koen M A DreijerinkDepartment 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.
Amsterdam University Medical Centers · NLVrije Universiteit Amsterdam · NLGender Studies · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFeminizing 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.

methodsThis 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: 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 registrationWHO 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 .

Indexed as

ProgesteroneTransgender PersonsAdultAndrogen AntagonistsEstradiolFemaleHumansMaleAndrogen AntagonistsEstradiolProgesteroneBreast developmentBreast volumeEstradiolGender-affirming hormone therapyProgesteroneTransgender

Identifiers

PMID38124194
PMCPMC10734173
OpenAlexW4390034859

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.