A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.

Phase 4

Completed

Brief Summary: Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males.

The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill.

Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug.

Required study activities include:

* Written informed consent

* Weight

* Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168

* Blood draws at the screening visit and Days 84, 112, 140, and 168

* Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits

* Medical history

You will continue in the treatment phase of the study for 12 weeks.

You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose.

Participation will be for 24-weeks.

Up to 10 investigational sites will enroll subjects into the study.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Minocycline Extended-Release Tablets	minocycline extended release	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Screening in Sperm Concentration.	Baseline and 12 Weeks

Secondary Outcome Measures

Name	Time	Method

Locations (10): Women's Health Research Center, LLC
🇺🇸
Lawrenceville, New Jersey, United States
Urology of Virginia, PC
🇺🇸
Virginia Beach, Virginia, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
West Coast Clinical Research
🇺🇸
Tarzana, California, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Weill Cornell Medical College
🇺🇸
Great Neck, New York, United States
Maze Laboratories
🇺🇸
Purchase, New York, United States
Urology San Antonio Research, PA
🇺🇸
San Antonio, Texas, United States
Tri-State Urologic Services, PSC, Inc.
🇺🇸
Cincinnati, Ohio, United States