A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Spermatogenesis
Intervention
minocycline extended release, Placebo
Location
West Coast Clinical Research
Tarzana
California
United States
91356
Status
Completed
Source
Medicis Pharmaceutical Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00765336
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Contact Lenses, Extended-wear
Hydrophilic contact lenses worn for an extended period or permanently.
Minocycline
A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Breech Presentation
A malpresentation of the FETUS at near term or during OBSTETRIC LABOR with the fetal cephalic pole in the fundus of the UTERUS. There are three types of breech: the complete breech with flexed hips and knees; the incomplete breech with one or both hips partially or fully extended; the frank breech with flexed hips and extended knees.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Clinical Trials
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline h...
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is...
It is hypothesized that reducing the frequency of dosing may increase subject compliance and providing the drug in an extended-release formulation may alleviate some of the side effects ob...
The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules foll...
Role of Minocycline in First Episode Psychosis
The purpose of this study is to determine whether the addition of minocycline or placebo to treatment as usual (TAU): 1. prevents the accumulation of negative symptoms and intellectual...
PubMed Articles
Minocycline attenuates subjective rewarding effects of dextroamphetamine in humans.
RATIONALE: Minocycline, a tetracycline antibiotic, interacts with brain glutamate and dopamine neurotransmission. In preclinical studies, minocycline attenuated amphetamine-induced acute dopamine rele...
A futility study of minocycline in Huntington's disease.
This study assessed the futility of proceeding with a Phase 3 clinical trial of minocycline as a disease-modifying treatment for Huntington's disease (HD). One hundred fourteen research participants w...
Effects of minocycline on Na(+) currents in rat dorsal root ganglion neurons.
Minocycline is an inhibitor of microglial activation and proliferation. Minocycline suppresses pain-related behaviors in many different pain states, which correlates closely with its inhibition of mic...
Minocycline treatment for HIV-associated cognitive impairment: Results from a randomized trial.
OBJECTIVE: We conducted a study of minocycline to assess its safety, tolerability, and efficacy for the treatment of HIV-associated cognitive impairment. METHODS: HIV-1-infected individuals with progr...
Extended-release pramipexole in advanced Parkinson disease: A randomized controlled trial.
BACKGROUND: In advanced Parkinson disease (PD), immediate-release pramipexole, taken 3 times daily, improves symptoms and quality of life. A once-daily extended-release formulation may be an effective...
