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

• Sponsor: Medicis Pharmaceutical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00765336
• Collaborator: (none)
• Enrollment: 180
• Locations: 10
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 18
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Human Volunteer	Drug: minocycline extended release; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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: Nov 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Placebo; placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Screening in Sperm Concentration. [Baseline and 12 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Research	Tarzana	California	United States	91356
2	University of Minnesota	Minneapolis	Minnesota	United States	55455-0341
3	Women's Health Research Center, LLC	Lawrenceville	New Jersey	United States	08648
4	Weill Cornell Medical College	Great Neck	New York	United States	11021
5	Maze Laboratories	Purchase	New York	United States	10577
6	Tri-State Urologic Services, PSC, Inc.	Cincinnati	Ohio	United States	45212
7	Baylor College of Medicine	Houston	Texas	United States	77030
8	Urology San Antonio Research, PA	San Antonio	Texas	United States	78229
9	University of Virginia	Charlottesville	Virginia	United States	22908
10	Urology of Virginia, PC	Virginia Beach	Virginia	United States	23454

Sponsors and Collaborators

• Medicis Pharmaceutical Corporation

Investigators

• Study Chair: Mary Sanstead, BSN, CCRP, Medicis Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medicis Pharmaceutical Corporation
• ClinicalTrials.gov Identifier: NCT00765336
• Other Study ID Numbers: MP-0104-18; IND 65,398
• First Posted: Oct 2, 2008
• Last Update Posted: Dec 7, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Medicis Pharmaceutical Corporation: Spermatogenesis in Healthy Males
• Additional relevant MeSH terms: Minocycline

Study Results

Participant Flow

Arm/Group Title	Minocycline Extended-Release Tablets	Placebo
Arm/Group Description	daily dose of 1 mg/kg minocycline extended-release tablets	daily dose of Placebo
Period Title: Overall Study
STARTED	91	89
COMPLETED	72	73
NOT COMPLETED	19	16

Baseline Characteristics

Arm/Group Title	Minocycline Extended-Release Tablets	Placebo	Total
Arm/Group Description	daily dose of 1 mg/kg minocycline extended-release tablets	daily dose of Placebo	Total of all reporting groups
Overall Participants	91	89	180
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	91 100%	89 100%	180 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.4 (11.0)	32.2 (9.0)	32.8 (10.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	91 100%	89 100%	180 100%
Region of Enrollment (participants) [Number]
United States	91 100%	89 100%	180 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Screening in Sperm Concentration.
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minocycline Extended-Release Tablets	Placebo
Arm/Group Description	daily dose of 1 mg/kg minocycline extended-release tablets	daily dose of Placebo
Measure Participants	72	73
Mean (Standard Deviation) [Percent change]	9.8 (58.3)	-1.3 (47.7)

Adverse Events

Time Frame	Posted adverse event data was collected during the treatment phase (through week 12)
Arm/Group Title	Minocycline Extended-Release Tablets		Placebo
Arm/Group Description	daily dose of 1 mg/kg minocycline extended-release tablets		daily dose of Placebo
All Cause Mortality
	Minocycline Extended-Release Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Minocycline Extended-Release Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		2/89 (2.2%)
Gastrointestinal disorders
Appendicitis	0/91 (0%)	0	1/89 (1.1%)	1
Musculoskeletal and connective tissue disorders
Back Injury	0/91 (0%)	0	1/89 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Minocycline Extended-Release Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/91 (36.3%)		27/89 (30.3%)
Gastrointestinal disorders
Gastrointestinal Disorders	8/91 (8.8%)		6/89 (6.7%)
Infections and infestations
Infections and Infestations	8/91 (8.8%)		9/89 (10.1%)
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications	3/91 (3.3%)		2/89 (2.2%)
Investigations
Investigations	5/91 (5.5%)		2/89 (2.2%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	4/91 (4.4%)		4/89 (4.5%)
Nervous system disorders
Nervous System Disorders	4/91 (4.4%)		3/89 (3.4%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	2/91 (2.2%)		7/89 (7.9%)
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders	11/91 (12.1%)		4/89 (4.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Specific restrictions and agreements are specified in each investigator's contract.