BACKGROUND: Danazol is a synthetic progestin with androgenic effects that is approved by the Food and Drug Administration for treatment of endometriosis, benign fibrocystic breast disease, and hereditary angioedema. In recent years, increasing numbers of transgender and nonbinary individuals seeking menstrual suppression have been offered danazol due to its potential to both induce amenorrhea and cause reversible androgenic side effects including pigmentation of vellus hairs and voice changes, which may be desirable in this population. There are currently no studies assessing use of danazol within the transgender population for menstrual suppression.
OBJECTIVE: This study's primary aim was to evaluate the use of danazol as a menstrual suppression agent in transgender patients.
DESIGN: This was a retrospective multisite cohort study of all individuals who had been on danazol at two tertiary care centers between 2000 and 2022.
METHODS: All patients prescribed danazol were identified using a search of the electronic medical records. For demographic purposes, comparisons were made between those who did and did not use danazol for the purpose of menstrual suppression. A detailed chart review was then performed to analyze the experiences of menstrual suppression in transgender and nonbinary patients.
RESULTS: Most transgender and nonbinary patients on danazol for menstrual suppression remained on it at their most recent follow-up visit, and many charts noted improvements in gender dysphoria, pelvic pain, dysmenorrhea, endometriosis, and heavy menstrual bleeding. Most transgender patients achieved amenorrhea.
CONCLUSION: Danazol may be a reasonable option for menstrual suppression in transgender and nonbinary patients. Our findings show its potential to not only induce amenorrhea but cause desired androgenic symptoms and improve gender dysphoria, pelvic pain, dysmenorrhea, endometriosis, and heavy bleeding. While the androgenic effects of danazol are less desirable in cisgender populations, it is an attractive option for menstrual suppression in transgender and nonbinary patients.
Our data suggest that danazol may be a plausible option for menstrual suppression in transgender and nonbinary patients.
a cautious clinical implication drawn from a small, uncontrolled retrospective cohort
At follow-up, 84.9% of transgender patients (N = 28) reported becoming amenorrheic.
a directly observed descriptive proportion with limited follow-up and no comparator
Most transgender and nonbinary patients on danazol for menstrual suppression remained on it at their most recent follow-up visit.
continuation was directly abstracted, though follow-up duration varied across patients
Many charts noted improvements in gender dysphoria, pelvic pain, dysmenorrhea, endometriosis, and heavy menstrual bleeding.
nonstandardized chart outcomes with unclear follow-up denominators for selected symptoms
Derived from the full evaluation — not a separate score.
Strengths
The study documents a previously unstudied use of danazol for menstrual suppression in transgender and nonbinary patients, including amenorrhea, persistence, dosing, and symptoms.
↳ Introduction, final paragraph; Results, Tables 2–3 narrative
The multisite chart review directly characterizes outcomes among danazol users and reports medians, interquartile ranges, frequencies, and varying denominators rather than presenting adjusted causal estimates.
↳ Methods; Statistical Analysis
The Discussion explains how retrospective documentation, limited follow-up, a predominantly White sample, and attention bias affect generalizability and confidence in symptom estimates.
↳ Discussion, limitations paragraph
Limitations
Symptom improvement and side effects were abstracted from clinical notes without standardized measures, leaving estimates vulnerable to documentation and attention bias.
↳ Discussion, limitations paragraph
The cohort includes no concurrent alternative menstrual-suppression arm, so the suggestion that danazol may be more attractive than other treatments is not directly tested.
↳ Conclusion, paragraph 1
The gender-dysphoria and pelvic-pain percentages imply smaller follow-up subsets than the baseline indication totals, but those follow-up denominators are not stated at the results.
↳ Results, gender-dysphoria and pelvic-pain paragraph
The study makes a meaningful first contribution by describing danazol use for menstrual suppression in 39 transgender patients across two tertiary centers. Its descriptive design supports reported amenorrhea and continuation proportions, but it cannot establish comparative effectiveness or explain who was selected to receive danazol. Symptom findings carry greater uncertainty because outcomes were not standardized and selected follow-up denominators are not stated transparently in the Results. The generally cautious conclusion is appropriate, although comparative language about attractiveness relative to other treatments exceeds the study’s direct evidence.
Nabu’s assessment, alongside the field’s view.
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Sound3.3
Confidence highThe study provides the first population-specific description of danazol for menstrual suppression in transgender and nonbinary patients, including amenorrhea, continuation, dosing, and symptoms. The advance remains narrow because the relevant cohort contains 39 patients and no comparator treatment.
“to date there have not been any studies about its use for primary menstrual suppression in the transgender population”
The multisite chart review is suitable for descriptive practice-pattern estimates and reports variable denominators, medians, and interquartile ranges. Treatment selection is not examined, and symptom outcomes rely on nonstandardized clinical documentation with limited follow-up.
“the outcomes of interest... were not standardized and were subject to interpretation and clinical documentation”
The manuscript presents a traceable progression from the clinical gap through descriptive findings to a generally qualified conclusion. Its statement that danazol may be more attractive than other treatments extends beyond the study’s noncomparative evidence but does not displace the principal descriptive interpretation.
“Our data suggest that danazol may be a plausible option”
The paper situates danazol among existing menstrual-suppression approaches and explains why androgenic effects may be valued differently in this population. The Discussion connects retrospective ascertainment, limited follow-up, sample composition, and documentation bias to interpretation and generalizability.
“Our study is limited by its retrospective nature, small sample size, and predominantly White sample”
Lower confidence on Contribution, Methodological Rigour — domain match limited.
Caveats4 of 4 checks
The main cohort totals and headline amenorrhea and continuation figures are coherent, but selected symptom-improvement percentages do not state their follow-up denominators transparently. These appear reconcilable through implied denominators rather than constituting demonstrated contradictions.
IRB approval, exempt status, consent waivers, and deidentification are declared in Methods. The generic online-supplement statement cannot be inspected from the supplied material and is recorded as an assessability gap, not a reliability concern.
Flags: 2 declared / 5 total
21 of 21 checkable references verified
23 references in manuscript 2 are books, websites or datasets — counted, but not index-checkable
References not verified automatically are resolved manually within 24 hours.
No retraction or expression of concern found in Crossref (includes Retraction Watch).
Sources: Crossref (incl. Retraction Watch) ✓
Where this paper’s evidence sits on the path from initial observation to real-world use.
The findings arise from real-world care at two centers, but the evidence remains an initial retrospective observation. No prospective comparison, standardized outcome protocol, or implementation and monitoring framework is supplied.
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