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

NCT00765336 | Completed Phase 4 Results DMC

• 2 other identifiers: MP-0104-18IND 65,398
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 10

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.

Conditions

Human Volunteer

Keywords

Spermatogenesis in Healthy Males

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Screening in Sperm Concentration.

  Baseline and 12 Weeks

Study Arms (2)

Minocycline Extended-Release Tablets

ACTIVE COMPARATOR

Drug: minocycline extended release

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

minocycline extended release DRUG

1 mg/kg extended release minocycline HCL, once daily for 84 days.

Minocycline Extended-Release Tablets

Placebo DRUG

placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Medicis Pharmaceutical Corporation: lead

Study Sites (10)

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455-0341, United States

Location

Women's Health Research Center, LLC

Lawrenceville, New Jersey, 08648, United States

Location

Weill Cornell Medical College

Great Neck, New York, 11021, United States

Location

Maze Laboratories

Purchase, New York, 10577, United States

Location

Tri-State Urologic Services, PSC, Inc.

Cincinnati, Ohio, 45212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Urology San Antonio Research, PA

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Urology of Virginia, PC

Virginia Beach, Virginia, 23454, United States

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Medicis Global Services Corporation

ClinicalTrials@Medicis.com

Study Officials

• Mary Sanstead, BSN, CCRP

  Medicis Pharmaceutical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 7, 2011
• Results First Posted: December 7, 2011

Record last verified: 2011-11

Locations

US (10)