Clinical trial NCT00765336: A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Volunteer
Keywords: Spermatogenesis in Healthy Males
Lead sponsor: Medicis Pharmaceutical Corporation
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Percent Change From Screening in Sperm Concentration.
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Lawrenceville
country: United States
facility: Women's Health Research Center, LLC
state: New Jersey
city: Great Neck
country: United States
facility: Weill Cornell Medical College
state: New York
city: Purchase
country: United States
facility: Maze Laboratories
state: New York
city: Cincinnati
country: United States
facility: Tri-State Urologic Services, PSC, Inc.
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PC
state: Virginia
Study officials:
affiliation: Medicis Pharmaceutical
name: Mary Sanstead, BSN, CCRP
role: STUDY_CHAIR
References: