Hormonal (dys)function in cluster headache

Hormonal (dys)function in cluster headache - Hormonal (dys)function in cluster headache

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51927

Enrollment

Registered

2020-07-27

Start date

2022-10-04

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cluster headache

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Male - Subjects need to be 18 years or older - Diagnosed with cluster headache (episodic or chronic) or no headache diagnosis

Exclusion criteria

Exclusion criteria: - Subjects are not allowed to use steroid or melatonin suppletion - Diagnosis of migraine - Disease effecting hormonal regulation

Design outcomes

Primary

Measure	Time frame
1. Difference in total testosterone between CCH patients versus ECH patients versus healthy controls 2. Difference in total testosterone between in males with ECH during remission (remission ECH) and during an active episode (active ECH).	—

Secondary

Measure	Time frame
Differences between androstenedione, DHEA, DHT and 11oxC19 steroids levels, testosterone/estrogen ratio, activin level, inhibin* level and morning cortisol level in blood between groups using various analysis: :To compare total testosterone levels between healthy controls and the remaining CH subgroups (ECH (active + remission) vs HC; CH (ECH & CCH) vs HC)To compare differences between hormonal pathways between subgroups.To compare differences between individual hormonal serum levels (androstenedione, DHEA, DHT and 11oxC19 level, testosterone/estrogen ratio, activin level, inhibin level, cortisol) between subgroups.To evaluate a possible correlation between testosterone levels and clinical symptoms of androgen deficiency as measured with the qADAM and AMS questionnaires in males with cluster headache. To evaluate a possible correlation between total testosterone levels and cluster attack frequency in males with cluster headache.	—

Measure

Time frame

Differences between androstenedione, DHEA, DHT and 11oxC19 steroids levels, testosterone/estrogen ratio, activin level*, inhibin** level and morning cortisol level in blood between groups using various analysis: :To compare total testosterone levels between healthy controls and the remaining CH subgroups (ECH (active + remission) vs HC; CH (ECH & CCH) vs HC)To compare differences between hormonal pathways between subgroups*.To compare differences between individual hormonal serum levels (androstenedione, DHEA, DHT and 11oxC19 level, testosterone/estrogen ratio, activin level, inhibin level, cortisol) between subgroups*.To evaluate a possible correlation between testosterone levels and clinical symptoms of androgen deficiency as measured with the qADAM and AMS questionnaires in males with cluster headache. To evaluate a possible correlation between total testosterone levels and cluster attack frequency in males with cluster headache.

—

Countries

Netherlands

Contacts

Public ContactWC Naber

Leids Universitair Medisch Centrum

cluster@lumc.nl0715262111

Outcome results