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

Information source: Medicis Pharmaceutical Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Volunteer

Intervention: minocycline extended release (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medicis Pharmaceutical Corporation

Official(s) and/or principal investigator(s):
Mary Sanstead, BSN, CCRP, Study Chair, Affiliation: Medicis Pharmaceutical

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Percent Change From Screening in Sperm Concentration.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

West Coast Clinical Research, Tarzana, California 91356, United States

University of Minnesota, Minneapolis, Minnesota 55455-0341, United States

Women's Health Research Center, LLC, Lawrenceville, New Jersey 08648, United States

Weill Cornell Medical College, Great Neck, New York 11021, United States

Maze Laboratories, Purchase, New York 10577, United States

Tri-State Urologic Services, PSC, Inc., Cincinnati, Ohio 45212, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Urology San Antonio Research, PA, San Antonio, Texas 78229, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Urology of Virginia, PC, Virginia Beach, Virginia 23454, United States

Additional Information

Starting date: November 2006
Last updated: November 2, 2011

Page last updated: August 23, 2015

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