Prostaglandin F2alpha in a Human Headache Model

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

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

Conditions
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Headache

Intervention / Treatment
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* Drug: Prostaglandin F2alpha
* Drug: Isoton sodium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Isoton sodium chloride<br> | Drug: Isoton sodium chloride<br>* intravenous injection<br>* Other names: placebo;|
| Active Comparator: Prostaglandin F2alpha<br> | Drug: Prostaglandin F2alpha<br>* intravenous injection<br>* Other names: Dinoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | incidence of headache | 24 h. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) | 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. | in-hospital 2 h. | 
| diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan | 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. | in-hospital 2 h. | 
| mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore® | 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. | in-hospital 2 h. | 
| electrocardiography (ECG) | 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. | in-hospital 2 h. |