A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00765336|
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : December 7, 2011
Last Update Posted : December 7, 2011
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
- 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 or disease||Intervention/treatment||Phase|
|Human Volunteer||Drug: minocycline extended release Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
|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||
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
- Mean Percent Change From Screening in Sperm Concentration. [ Time Frame: Baseline and 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765336
|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|
|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|
|Study Chair:||Mary Sanstead, BSN, CCRP||Medicis Pharmaceutical|