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

Human Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765336
• Other study ID #: MP-0104-18
• Secondary ID: IND 65,398
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: November 2, 2011
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2011
• Source: Medicis Pharmaceutical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Human Volunteer

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Tri-State Urologic Services, PSC, Inc.	Cincinnati	Ohio
United States	Weill Cornell Medical College	Great Neck	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Women's Health Research Center, LLC	Lawrenceville	New Jersey
United States	University of Minnesota	Minneapolis	Minnesota
United States	Maze Laboratories	Purchase	New York
United States	Urology San Antonio Research, PA	San Antonio	Texas
United States	West Coast Clinical Research	Tarzana	California
United States	Urology of Virginia, PC	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change From Screening in Sperm Concentration.		Baseline and 12 Weeks	Yes