Trial Outcomes & Findings for NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) (NCT NCT00322465)
NCT ID: NCT00322465
Last Updated: 2019-03-01
Results Overview
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
305 participants
Primary outcome timeframe
First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Results posted on
2019-03-01
Participant Flow
Participant milestones
| Measure |
Doxycycline
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Doxycycline + Tinidazole
Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
|
Azithromycin
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
73
|
77
|
79
|
|
Overall Study
COMPLETED
|
56
|
49
|
51
|
53
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
26
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Baseline characteristics by cohort
| Measure |
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Doxycycline + Tinidazole
n=73 Participants
Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
298 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
25.7 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
26.8 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
305 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
73 participants
n=7 Participants
|
77 participants
n=5 Participants
|
79 participants
n=4 Participants
|
305 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea
|
4 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
At all study visits, unsolicited adverse events were recorded.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain
|
5 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea
|
3 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo
Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: \[Persistent symptoms AND \>= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)\] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: \>= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
|
51 Percentage of participants
Interval 37.4 to 61.3
|
47 Percentage of participants
Interval 40.8 to 64.2
|
39 Percentage of participants
Interval 49.3 to 72.0
|
48 Percentage of participants
Interval 40.4 to 63.3
|
SECONDARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: \[Persistent symptoms AND \>= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)\] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: \>= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=156 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=149 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)
|
44 Percentage of participants
|
49 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=24 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=34 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=26 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=25 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
|
75 Percentage of participants
|
89 Percentage of participants
|
66 Percentage of participants
|
61 Percentage of participants
|
SECONDARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=9 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=9 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=7 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=5 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
|
75 Percentage of participants
|
55 Percentage of participants
|
56 Percentage of participants
|
50 Percentage of participants
|
SECONDARY outcome
Timeframe: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Population: Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=18 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=21 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=22 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=23 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
|
32 Percentage of participants
|
23 Percentage of participants
|
52 Percentage of participants
|
68 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (enrollment visit)Population: All study participants with evaluable baseline test results.
Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis
|
38 Percentage of participants
|
50 Percentage of participants
|
38 Percentage of participants
|
46 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (enrollment visit)Population: All study participants with evaluable baseline test results.
Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=77 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis
|
16 Percentage of participants
|
14 Percentage of participants
|
12 Percentage of participants
|
10 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (enrollment)Population: All study participants with evaluable baseline test results.
Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
n=73 Participants
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=76 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
n=76 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 Participants
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis
|
30 Percentage of participants
|
29 Percentage of participants
|
32 Percentage of participants
|
32 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (enrollment visit)Population: All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.
Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=290 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis
Positive for Chlamydia Trachomatis at Baseline
|
—
|
128 Participants
|
—
|
—
|
|
Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis
Negative for Chlamydia Trachomatis at Baseline
|
—
|
162 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (enrollment visit)Population: All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.
Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=291 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis
Positive for Trichomonas Vaginalis at Baseline
|
—
|
38 Participants
|
—
|
—
|
|
Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis
Negative for Trichomonas Vaginalis at Baseline
|
—
|
253 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (enrollment visit)Population: All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.
Logistic multiple regression with independent variable selection based on single variable models with p\<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.
Outcome measures
| Measure |
Azithromycin + (Azithromycin + Tinidazole)
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
|
Doxycycline
n=292 Participants
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Azithromycin
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis
Positive for Mycoplasma Genitalium at Baseline
|
—
|
90 Participants
|
—
|
—
|
|
Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis
Negative for Mycoplasma Genitalium at Baseline
|
—
|
202 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis
Outcome measures
Outcome data not reported
Adverse Events
Doxycycline
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Doxycycline + Tinidazole
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Azithromycin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Azithromycin + Tinidazole
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxycycline
n=76 participants at risk
Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
|
Doxycycline + Tinidazole
n=73 participants at risk
Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
|
Azithromycin
n=77 participants at risk
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
|
Azithromycin + Tinidazole
n=79 participants at risk
Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
6/76 • Number of events 6 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
6.8%
5/73 • Number of events 5 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
3.9%
3/77 • Number of events 3 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
6.3%
5/79 • Number of events 5 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
General disorders
Bloody discharge
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
4.1%
3/73 • Number of events 3 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
3.9%
3/77 • Number of events 3 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
8.9%
7/79 • Number of events 7 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
General disorders
Fatigue
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
General disorders
Feeling hot
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Genital Herpes
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Genital lesion
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Genital ulceration
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Nervous system disorders
Headache
|
5.3%
4/76 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
5.5%
4/73 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
2.5%
2/79 • Number of events 3 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Nervous system disorders
Light headedness/ dizziness
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
2.5%
2/79 • Number of events 2 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
3/76 • Number of events 7 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
5.5%
4/73 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
5.1%
4/79 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
General disorders
Pain
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Rosea
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Infections and infestations
Respiratory infection/ respiratory tract infection
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Infections and infestations
Sinus infection/ sinusitis
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Nervous system disorders
Somnolence
|
1.3%
1/76 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Injury, poisoning and procedural complications
Spider bite/ anthropod bite
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Stomach upset/ stomach discomfort
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Nervous system disorders
Taste abnormality/ disgeusia
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
8.2%
6/73 • Number of events 6 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
5.1%
4/79 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.4%
1/73 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/77 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
4/76 • Number of events 4 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
2.7%
2/73 • Number of events 2 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/79 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
|
Injury, poisoning and procedural complications
Wrist sprain/ joint sprain
|
0.00%
0/76 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/73 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
0.00%
0/77 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
1.3%
1/79 • Number of events 1 • Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
|
Additional Information
Jane R. Schwebke, MD
University of Alabama at Birmingham
Phone: (205) 975-5665
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place