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

A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males

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.

Study Overview

• Status: Completed
• Conditions: Human Volunteer
• Intervention / Treatment: Drug: minocycline extended release; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Tarzana, California, United States, 91356
      • West Coast Clinical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455-0341
      • University of Minnesota
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Women's Health Research Center, LLC
  • New York
    • Great Neck, New York, United States, 11021
      • Weill Cornell Medical College
    • Purchase, New York, United States, 10577
      • Maze Laboratories
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Tri-State Urologic Services, PSC, Inc.
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research, PA
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Urology of Virginia, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
Active Comparator: Minocycline Extended-Release Tablets	Drug: minocycline extended release; 1 mg/kg extended release minocycline HCL, once daily for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Percent Change From Screening in Sperm Concentration.	Baseline and 12 Weeks

Collaborators and Investigators

• Sponsor: Medicis Pharmaceutical Corporation
• Investigators: Study Chair: Mary Sanstead, BSN, CCRP, Medicis Pharmaceutical

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): December 7, 2011
• Last Update Submitted That Met QC Criteria: November 2, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Spermatogenesis in Healthy Males
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: MP-0104-18; IND 65,398