Exploring sexual function in adrenal insufficiency: findings from the Dual RElease hydrocortisone versus conventionAl glucocorticoid replaceMent therapy in hypocortisolism (DREAM) trial.
Hasenmajer V, De Alcubierre D, et al. • Andrology • 2025
Sexual dysfunction is common in adrenal insufficiency patients and is likely explained by multiple factors; dual-release hydrocortisone treatment is not directly associated with sexual function improvement, but an indirect effect mediated by quality-of-life amelioration cannot be excluded.
Key Findings
Results
Sexual dysfunction was prevalent in both women and men with adrenal insufficiency at baseline.
Sexual dysfunction was observed in 41% of women and 59% of men with adrenal insufficiency at baseline.
63 patients (34 women) consented to sex steroid measurements and questionnaire completion.
Sexual function was assessed using the Female Sexual Function Index (FSFI) for women and the International Index of Erectile Function-Erectile Function (IIEF-EF) for men.
Results
No associations were found between sexual function and hormone levels in either sex.
In both sexes, no associations were found between sexual function scores and sex steroid hormone levels at baseline.
Sex steroid measurements were obtained alongside questionnaire completion at baseline and at 24 weeks after randomization.
Results
Quality of life scores positively correlated with sexual function scores in both sexes.
Addison's disease-specific quality-of-life questionnaire (AddiQoL) total and fatigue domain scores positively correlated with total FSFI and IIEF-EF scores.
This association was observed in both women and men with adrenal insufficiency.
The correlation suggests that quality of life, rather than hormone levels, may be a key mediator of sexual function in this population.
Results
Switching to dual-release hydrocortisone did not produce a significant difference in sexual function or sex steroid levels compared to conventional therapy at 24 weeks.
At 24 weeks, there was no significant difference either in sexual function or sex steroid levels between the dual-release hydrocortisone group and the conventional glucocorticoid replacement group.
89 adrenal insufficiency patients on conventional multiple daily doses of glucocorticoid replacement were randomly assigned to continue their therapy or switch to an equivalent dose of dual-release hydrocortisone.
The trial was an outcome assessors blinded, randomized, multicenter, active comparator clinical trial (DREAM trial).
Patients included those with both primary and secondary adrenal insufficiency.
Results
In the dual-release hydrocortisone group, improvement in sexual desire was positively associated with improvement in disease-specific symptom scores.
In the dual-release hydrocortisone group, the variation in the FSFI desire domain score was positively associated with the change in AddiQoL symptom domain score (ρ = 0.478, p = 0.045).
This association suggests a potential indirect effect of dual-release hydrocortisone on sexual function mediated through quality-of-life improvement.
This finding was specific to the dual-release hydrocortisone treatment group and was not reported for the conventional therapy group.
Methods
The study population included patients with both primary and secondary adrenal insufficiency enrolled in the DREAM trial.
89 adrenal insufficiency patients on conventional, multiple daily doses of glucocorticoid replacement were enrolled.
63 patients (34 women) consented to sex steroid measurements and questionnaire completion for quality of life and sexual function evaluation.
Assessments were conducted at baseline and 24 weeks after randomization.
The DREAM trial was a randomized, multicenter, active comparator clinical trial with outcome assessors blinded to treatment allocation.
Hasenmajer V, De Alcubierre D, Ferrari D, Minnetti M, Bonaventura I, Pofi R, et al.. (2025). Exploring sexual function in adrenal insufficiency: findings from the Dual RElease hydrocortisone versus conventionAl glucocorticoid replaceMent therapy in hypocortisolism (DREAM) trial.. Andrology. https://doi.org/10.1111/andr.13635