CLINICAL TRIALS PROFILE FOR MONODOX

All Clinical Trials for MONODOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00358462 ↗	Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2007-01-01	The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00358462 ↗	Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)	Completed	University of Washington	Phase 3	2007-01-01	The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00652704 ↗	Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions	Completed	Anapharm	Phase 1	1999-07-01	To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)

Clinical Trial Conditions for MONODOX

Condition Name

Condition Name for MONODOX
Intervention	Trials
To Determine Bioequivalence Under Fasting Conditions	3
To Determine Bioequivalence Under Fed Conditions	2
To Determine Bioequivalence Under Fed Conditions.	2

Condition MeSH

Condition MeSH for MONODOX
Intervention	Trials
Disease	5
Urethritis	1
Disease Susceptibility	1

Clinical Trial Locations for MONODOX

Trials by Country

Trials by Country for MONODOX
Location	Trials
Canada	5
United States	2

Trials by US State

Trials by US State for MONODOX
Location	Trials
Pennsylvania	1
Washington	1

Clinical Trial Progress for MONODOX

Clinical Trial Phase

Clinical Trial Phase for MONODOX
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	5
N/A	1

Clinical Trial Status

Clinical Trial Status for MONODOX
Clinical Trial Phase	Trials
Completed	6
Withdrawn	1

Clinical Trial Sponsors for MONODOX

Sponsor Name

Sponsor Name for MONODOX
Sponsor	Trials
Anapharm	5
Par Pharmaceutical, Inc.	5
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for MONODOX
Sponsor	Trials
Industry	10
Other	2
NIH	1