Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medicis Pharmaceutical Corporation
Age
18–any
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Males at least 18 years of age
Weight 45 kg - 136.36 kg (99-300 lbs)
Must understand and give consent voluntarily to be in the study and to comply with study requirements
Subjects must ejaculate between 48 and 72 hours prior to collection of the first specimen (Pre-Collection Ejaculation) and refrain from further ejaculation until Specimen 1 is collected. The second ejaculation sample Specimen 2) must be collected between 48 hours and 72 hours after Specimen 1. No ejaculation is permitted between Specimen 1 and Specimen 2
Must refrain from using saunas or hot tubs during the duration of the study 168 days)
Must be a non smoker
Must be medically healthy as determined by the investigator physician (via medical history and clinical laboratory tests)
Must have sperm parameters (average of Specimen 1 and Specimen 2) within clinically acceptable limits at screening defined as:
Total sperm concentration ≥20 x 106/mL10
% motile ≥50%10
% normal morphology \>4.4%14
You may not be if
Known allergy/sensitivity to minocycline or any of the other drug product components
Use of antacids or other dietary supplements containing aluminum, calcium, iron, or magnesium
History of vestibular incidents including vertigo, lightheadedness, nausea, or vomiting within the 30 days prior to enrollment
Known history of alcohol or drug dependency, significant within the past 2 years
Known history or current risk of hepatic dysfunction
Known history or current risk of renal dysfunction, e.g., uncontrolled diabetes
Systemic lupus erythematosis (SLE) or a positive ANA at screening
Receipt of any experimental drugs within 120 days prior to Study Day 0
Non-LFT clinical laboratory values outside the normal range and determined to be of clinical significance
Liver function tests greater than 1.5 times the upper limit of normal (ALT, AST, GGT)
Use of tetracyclines, erythromycin within 12 weeks of Day 0
Clareo Health | A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
