|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Medicis Pharmaceutical Corporation |
|---|---|
| Information provided by: | Medicis Pharmaceutical Corporation |
| ClinicalTrials.gov Identifier: | NCT00765336 |
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:
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 |
|---|---|---|
|
Spermatogenesis |
Drug: minocycline extended release Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males |
| Enrollment: | 180 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Minocycline Extended-Release Tablets: Active Comparator | Drug: minocycline extended release |
| Placebo: Placebo Comparator | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Maze Laboratories | |
| Purchase, New York, United States, 10577 | |
| Weill Cornell Medical College | |
| Great Neck, New York, United States, 11021 | |
| 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 | |
| Urology of Virginia, PC | |
| Virginia Beach, Virginia, United States, 23454 | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Mary Sanstead, RN, BSN, CCRP | Medicis Pharmaceutical |
More Information
| Responsible Party: | Medicis Pharmaceutical Corporation ( Mary Sanstead, RN, BSN, CCRP ) |
| Study ID Numbers: | MP-0104-18, IND 65,398 |
| Study First Received: | September 30, 2008 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00765336 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Spermatogenesis in Human Males |
|
Anti-Infective Agents Anti-Bacterial Agents Minocycline Therapeutic Uses Pharmacologic Actions |