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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Pharmaceutical Corporation
ClinicalTrials.gov Identifier:
NCT00765336
First received: September 30, 2008
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Human Volunteer
Drug: minocycline extended release
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males

Resource links provided by NLM:


Further study details as provided by Medicis Pharmaceutical Corporation:

Primary Outcome Measures:
  • Mean Percent Change From Screening in Sperm Concentration. [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: November 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minocycline Extended-Release Tablets Drug: minocycline extended release
1 mg/kg extended release minocycline HCL, once daily for 84 days.
Placebo Comparator: Placebo Drug: Placebo
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765336

Locations
United States, California
West Coast Clinical Research
Tarzana, California, United States, 91356
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0341
United States, New Jersey
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States, 08648
United States, New York
Weill Cornell Medical College
Great Neck, New York, United States, 11021
Maze Laboratories
Purchase, New York, United States, 10577
United States, Ohio
Tri-State Urologic Services, PSC, Inc.
Cincinnati, Ohio, United States, 45212
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Urology of Virginia, PC
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Medicis Pharmaceutical Corporation
Investigators
Study Chair: Mary Sanstead, BSN, CCRP Medicis Pharmaceutical
  More Information

No publications provided

Responsible Party: Medicis Pharmaceutical Corporation
ClinicalTrials.gov Identifier: NCT00765336     History of Changes
Other Study ID Numbers: MP-0104-18, IND 65,398
Study First Received: September 30, 2008
Results First Received: September 28, 2011
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicis Pharmaceutical Corporation:
Spermatogenesis in Healthy Males

Additional relevant MeSH terms:
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014