Impact of Oral vs. Transdermal Oestrogen on Cortisol & CBG Before SST
Cortisol · Cortisol Binding Globulin
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 90 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- No informado
- Participantes
- 1 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Cortisol is a hormone that helps the body handle stress and maintain blood pressure. Doctors check if the adrenal glands (which make cortisol) are working correctly using a Synacthen test (SST). This test involves giving a drug that stimulates cortisol production and measuring how much is released.
For women taking oestrogen pills (found in birth control and hormone replacement therapy), the test results can be misleading. Oestrogen increases a substance in the blood called cortisol-binding globulin (CBG), which attaches to cortisol and makes some of it inactive. When doctors measure cortisol, they check both active and inactive forms. If CBG is high, the test can falsely suggest cortisol levels are normal, making it harder to tell if the adrenal glands are working correctly.
To avoid this problem, women taking oestrogen pills and gels/patches (transdermal) are asked to stop for 6 weeks before the test so that CBG/cortisol levels return to normal. However, this can cause uncomfortable symptoms like hot flushes, mood swings, and headaches.
Some women use transdermal oestrogen, which is absorbed through the skin instead. Unlike pills, there is some evidence that transdermal oestrogen doesn't affect CBG levels meaning women using them may not need to stop before an SST. This study will provide more evidence confirming that transdermal oestrogen is safe to continue before testing.
We will study three groups: women taking oestrogen pills, women using gel/patches, and women not taking oestrogen. By measuring CBG and cortisol every week, we aim to find out exactly when CBG returns to normal after stopping oestrogen pills. If it happens before 6 weeks, doctors may be able to shorten the break, making testing more manageable and more comfortable.
This research could improve testing for women taking oestrogen, potentially allowing those on gel/patches to continue treatment and those on pills to pause for a shorter time before testing.
¿Quién podría participar?
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Inclusion Criteria:
- Female patients aged 18 to 70 years.
- Scheduled to undergo a Short Synacthen Test (SST) as part of routine clinical care.
- Currently taking oral or transdermal oestrogen therapy for ≥3 months, or not on oestrogen (control group).
- Willing and able to provide informed consent.
- Willing and able to discontinue oestrogen therapy (if applicable) for 6 weeks.
- Willing and able to provide weekly blood and saliva samples over a 6-week period.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Significant liver dysfunction, defined as ALT or AST \>2× the upper limit of normal, or low albumin (\<25 g/L).
- Currently taking glucocorticoids above replacement dose or have done so in the past 6 months.
- Recent intra articular steroid injection (within 12 weeks)
- Unable to comply with study procedures or follow-up schedule.
- Individuals who were not assigned female sex at birth
- Women using oestrogen hormone-modulating medications
- Chronic kidney disease affecting hormone metabolism
- Diagnosed with adrenal insufficiency or any known pituitary or adrenal disorder that could affect cortisol production.
- Any endocrine disorder (e.g., Cushing's syndrome, uncontrolled thyroid disease) that could interfere with the study results
- Use of drugs that significantly alter liver metabolism (e.g., anticonvulsants, rifampicin), as they may impact CBG levels.
Población del estudio
Norfolk and Norwich University Hospitals NHS Foundation Trust
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
Oral oestrogen group
Women taking oestrogen pills - They will stop taking them for up to six weeks, as required for standard care.
Transdermal oestrogen group
Women using oestrogen gel or patches - They will stop taking them for up to six weeks, as required for standard care.
Control group
Women not taking any oestrogen - This control group will help compare results.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Changes in cortisol binding globulin (CBG) concentration and serum cortisol levels
Plazo: 6 weeks
The primary outcome measures are the changes in cortisol binding globulin (CBG) concentration and serum cortisol levels over a six-week period following the discontinuation of oral or transdermal oestrogen therapy. These will be assessed through weekly blood samples, with additional comparison to salivary cortisol levels.
The aim is to evaluate the impact of oestrogen route on CBG and cortisol levels, and to determine whether the current 6-week cessation period for oral oestrogen prior to the Short Synacthen Test (SST) can be safely shortened. This could improve test accuracy, patient experience, and potentially support the continued use of transdermal oestrogen without interruption.
Medidas secundarias
Salivary cortisol and cortisone levels
Plazo: 6 weeks
Salivary cortisol and cortisone levels measured weekly over the 6-week period, to evaluate their potential as non-invasive alternatives to serum cortisol for assessing adrenal function.
Revisa las tablas completas y sus limitaciones en el registro oficial.
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1 centros
Norfolk and Norwich University Hospitals NHS Foundation TrustNorwich, Norfolk, United KingdomEstado desconocido
Equipo y fechas
- Patrocinador principal
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Inicio del estudio
- 16 feb 2026 Real
- Finalización primaria
- 12 ago 2026 Real
- Finalización del estudio
- 12 ago 2026 Real
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Comparing the Impact of Oral and Transdermal Oestrogen on Cortisol Binding Globulin and Cortisol Levels Before Short Synacthen Test
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026