Prostaglandin F2alpha in a Human Headache Model

Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327118

Enrollment

Registered

2011-04-01

Start date

2010-09-30

Completion date

2010-12-31

Last updated

2011-04-14

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

Conditions

Headache

Brief summary

The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.

Interventions

DRUGProstaglandin F2alpha

intravenous injection

DRUGIsoton sodium chloride

intravenous injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Primary Headache * Headache on the day of the investigation * Hypertension * Hypotension * Pregnant/nursing * Daily intake of medication (except oral contraceptives) * Cardiovascular or central nervous system (CNS) disease * Drug/alcohol abuse * Psychiatric disease

Design outcomes

Primary

Measure	Time frame	Description
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache	24 h.	incidence of headache

Secondary

Measure	Time frame	Description
diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
electrocardiography (ECG)	in-hospital 2 h.	changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026