Phase 4
N=180
A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
Human Volunteer
Bottom Line
View on ClinicalTrials.gov: NCT00765336 ↗Enrolled (actual)
180
Serious AEs
1.1%
Results posted
Dec 2011
Primary outcome: Primary: Mean Percent Change From Screening in Sperm Concentration. — 9.8; -1.3 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- minocycline extended release (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Medicis Pharmaceutical Corporation
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Screening in Sperm Concentration. |
9.8; -1.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00765336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.