Trial Outcomes & Findings for A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males. (NCT NCT00765336)

NCT ID: NCT00765336

Last Updated: 2011-12-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Baseline and 12 Weeks
• Results posted on: 2011-12-07

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Minocycline Extended-Release Tablets daily dose of 1 mg/kg minocycline extended-release tablets	Placebo daily dose of Placebo
Overall Study Protocol Violation	4	2
Overall Study Withdrawal by Subject	6	4
Overall Study Lost to Follow-up	7	9
Overall Study Adverse Event	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Minocycline Extended-Release Tablets n=91 Participants daily dose of 1 mg/kg minocycline extended-release tablets	Placebo n=89 Participants daily dose of Placebo	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	33.4 years STANDARD_DEVIATION 11.0 • n=5 Participants	32.2 years STANDARD_DEVIATION 9.0 • n=7 Participants	32.8 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	89 participants n=7 Participants	180 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

Population: 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.

Outcome measures

Measure	Minocycline Extended-Release Tablets n=72 Participants daily dose of 1 mg/kg minocycline extended-release tablets	Placebo n=73 Participants daily dose of Placebo
Mean Percent Change From Screening in Sperm Concentration.	9.8 Percent change Standard Deviation 58.3	-1.3 Percent change Standard Deviation 47.7

Adverse Events

Minocycline Extended-Release Tablets

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Minocycline Extended-Release Tablets n=91 participants at risk daily dose of 1 mg/kg minocycline extended-release tablets	Placebo n=89 participants at risk daily dose of Placebo
Gastrointestinal disorders Appendicitis	0.00% 0/91 • Posted adverse event data was collected during the treatment phase (through week 12)	1.1% 1/89 • Number of events 1 • Posted adverse event data was collected during the treatment phase (through week 12)
Musculoskeletal and connective tissue disorders Back Injury	0.00% 0/91 • Posted adverse event data was collected during the treatment phase (through week 12)	1.1% 1/89 • Number of events 1 • Posted adverse event data was collected during the treatment phase (through week 12)

Other adverse events

Measure	Minocycline Extended-Release Tablets n=91 participants at risk daily dose of 1 mg/kg minocycline extended-release tablets	Placebo n=89 participants at risk daily dose of Placebo
Infections and infestations Infections and Infestations	8.8% 8/91 • Posted adverse event data was collected during the treatment phase (through week 12)	10.1% 9/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	3.3% 3/91 • Posted adverse event data was collected during the treatment phase (through week 12)	2.2% 2/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Investigations Investigations	5.5% 5/91 • Posted adverse event data was collected during the treatment phase (through week 12)	2.2% 2/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Nervous system disorders Nervous System Disorders	4.4% 4/91 • Posted adverse event data was collected during the treatment phase (through week 12)	3.4% 3/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	12.1% 11/91 • Posted adverse event data was collected during the treatment phase (through week 12)	4.5% 4/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Gastrointestinal disorders Gastrointestinal Disorders	8.8% 8/91 • Posted adverse event data was collected during the treatment phase (through week 12)	6.7% 6/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	2.2% 2/91 • Posted adverse event data was collected during the treatment phase (through week 12)	7.9% 7/89 • Posted adverse event data was collected during the treatment phase (through week 12)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	4.4% 4/91 • Posted adverse event data was collected during the treatment phase (through week 12)	4.5% 4/89 • Posted adverse event data was collected during the treatment phase (through week 12)

Additional Information

Director of Clinical Trials

Medicis Global Services Corporation

Email: ClinicalTrials@Medicis.com

Results disclosure agreements

• Principal investigator is a sponsor employee Specific restrictions and agreements are specified in each investigator's contract.
• Publication restrictions are in place

Restriction type: OTHER