Here is the design of a clinical trial:

Official Title: Randomized Double-blind Placebo-controlled Trial on the Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Included conditions:
- Prostatic Hyperplasia

Study Armgroups:
- {'label': 'Active drug', 'type': 'EXPERIMENTAL', 'description': 'dexamethasone 24 mg i.v., single dose', 'interventionNames': ['Drug: Dexamethasone']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'saline i.v., single dose', 'interventionNames': ['Drug: Saline']}

Interventions:
- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.', 'armGroupLabels': ['Active drug']}
- {'type': 'DRUG', 'name': 'Saline', 'description': 'The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.', 'armGroupLabels': ['Placebo']}

Primary Outcomes:
- {'measure': 'Body temperature', 'description': 'Mean rectal body temperature, measured in degrees Celsius', 'timeFrame': 'Measured by participant on Day 2 following PAE,'}
- {'measure': 'Postprocedural pain', 'description': 'Mean postprocedural pain measured on Brief Pain Inventory Short Form (BPI-SF), score on a 0-10 scale, higher score indicates higher level of pain', 'timeFrame': 'During the first 5 days following PAE'}
- {'measure': 'Postprocedural quality of life', 'description': 'Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life', 'timeFrame': 'During the first 5 days following PAE'}

Please estimate the sample size based on the assumption: 
One-sided two-sample t-test, 80% power, significance level of 0.05, compensation for dropouts.
Sample size
        A pilot study conducted at the Department of Urology, Rigshospitalet on four patients undergoing PAE (without DEXA administration) showed a mean postprocedural rectal temperature of 37.8Â°C (SD 0.38) 2âdays post-PAE. Day 2 is chosen as study target as it had the highest mean temperature of the 5âdays in which the temperature was measured. The goal reduction is from mean temperature on day 2 (subfebrile) to a mean of 37.4Â°C (afebrile). A one-sided two-sample t-test power calculation with 80% power and a significance of 0.05 gives a required sample size of 28 patients in each group or 56 patients in total.
        In the literature, a 3-point decrease (SD 2) on the BPI-SF questionnaire is considered clinically relevant.23 24 With that in mind, a one-sided two-sample t-test power calculation with 80% power and a significance of 0.05 gives a required sample size of 7 patients in each group or 14 patients in total.
        In conclusion, this study will include 30 patients in each group (60 in total) to compensate for eventual dropouts. Dropouts are defined as patients who, after inclusion, either do not receive the allocated trial medication or are lost to follow-up for the primary outcomes.
        The study has not been powered for the secondary outcome measures.