Human VolunteerPhase 4NCT00765336

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

A Phase 4 study testing minocycline extended release in people with Human Volunteer, run by Medicis Pharmaceutical Corporation at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Human Volunteer
What is being tested?: minocycline extended release
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 10 sitesUnited States
Study dates: Nov 2006to Jan 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Virginia
Charlottesville, Virginia, 22908
Tri-State Urologic Services, PSC, Inc.
Cincinnati, Ohio, 45212
Weill Cornell Medical College
Great Neck, New York, 11021
Baylor College of Medicine
Houston, Texas, 77030
Women's Health Research Center, LLC
Lawrenceville, New Jersey, 08648
University of Minnesota
Minneapolis, Minnesota, 55455-0341
Maze Laboratories
Purchase, New York, 10577
Urology San Antonio Research, PA
San Antonio, Texas, 78229
West Coast Clinical Research
Tarzana, California, 91356
Urology of Virginia, PC
Virginia Beach, Virginia, 23454

Other trials in United States

About this study

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

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.

Conditions: Human Volunteer
Being tested: minocycline extended release, Placebo
Keywords: Spermatogenesis in Healthy Males

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

minocycline extended releaseDrug
1 mg/kg extended release minocycline HCL, once daily for 84 days.
PlaceboDrug
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

Study groups in NCT00765336
Study group	Role	What they receive
Minocycline Extended-Release Tablets	Active comparator	Not described Receives: Drug: minocycline extended release
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent Change From Screening in Sperm Concentration.
Measured: Baseline and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jan 2009

First posted2 Oct 2008 (estimated)
Study startNov 2006
Primary completionDec 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human VolunteerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765336
Sponsor's protocol ID: MP-0104-18
Other IDs: IND 65,398
Status last verified: Nov 2011
First submitted: 30 Sep 2008
Last updated: 7 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

All Human Volunteer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males
ClinicalTrials.gov ID: NCT00765336
Acronym / sponsor ID: MP-0104-18
Conditions: Human Volunteer
Keywords: Spermatogenesis in Healthy Males
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Medicis Pharmaceutical CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 7 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Minocycline Extended-Release Tablets	Active comparator	Drug: minocycline extended release
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
minocycline extended release1 mg/kg extended release minocycline HCL, once daily for 84 days.	Drug	Minocycline Extended-Release Tablets
Placeboplacebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.	Drug	Placebo

Primary outcome

Mean Percent Change From Screening in Sperm Concentration.
Time frame: Baseline and 12 Weeks

Results and safety

Results posted to the registry on 7 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Minocycline Extended-Release Tablets	91	72
Placebo	89	73

Primary outcome: Mean Percent Change From Screening in Sperm Concentration.

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: Percent change

Measure	Minocycline Extended-Release Tablets n = 72	Placebo n = 73
Value	9.8 (58.3)	-1.3 (47.7)

Population analysed: The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.

Adverse events

Time frame: Posted adverse event data was collected during the treatment phase (through week 12). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Minocycline Extended-Release Tablets	0 of 91 (0%)	33 of 91 (36.3%)	Not reported
Placebo	2 of 89 (2.2%)	27 of 89 (30.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Volunteer

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Sanstead, BSN, CCRP study chair

Medicis Pharmaceutical

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing minocycline extended release in people with Human Volunteer, run by Medicis Pharmaceutical Corporation at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change From Screening in Sperm Concentration. (time frame: Baseline and 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00765336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.