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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR DINOPROSTONE

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Clinical Trials for Dinoprostone

Trial ID Title Status Sponsor Phase Summary
NCT00140114 Sublingual Versus Vaginal Misoprostol for Labor Induction at Term Completed American University of Beirut Medical Center Phase 3 Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00148473 Oral Versus Vaginal Misoprostol for Induction of Labor Completed Bangkok Metropolitan Administration Medical College and Vajira Hospital Phase 2/Phase 3 The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
NCT00299754 Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) Completed National Healthcare Group, Singapore Phase 3 Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00299754 Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) Completed KK Women's and Children's Hospital Phase 3 Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00308711 Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor Completed Ferring Pharmaceuticals Phase 3 The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dinoprostone

Condition Name

Condition Name for Dinoprostone
Intervention Trials
Cervical Ripening 12
Induction of Labor 8
Labor Induction 4
Pregnancy 4
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Condition MeSH

Condition MeSH for Dinoprostone
Intervention Trials
Rupture 3
Fetal Membranes, Premature Rupture 3
Migraine Disorders 1
Headache 1
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Clinical Trial Locations for Dinoprostone

Trials by Country

Trials by Country for Dinoprostone
Location Trials
United States 45
Japan 10
Korea, Republic of 5
France 4
Canada 4
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Trials by US State

Trials by US State for Dinoprostone
Location Trials
Oregon 2
California 2
Pennsylvania 2
South Carolina 2
Tennessee 2
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Clinical Trial Progress for Dinoprostone

Clinical Trial Phase

Clinical Trial Phase for Dinoprostone
Clinical Trial Phase Trials
Phase 4 8
Phase 3 13
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Dinoprostone
Clinical Trial Phase Trials
Completed 19
Recruiting 11
Not yet recruiting 8
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Clinical Trial Sponsors for Dinoprostone

Sponsor Name

Sponsor Name for Dinoprostone
Sponsor Trials
Ferring Pharmaceuticals 7
Seoul National University Hospital 5
Ain Shams University 3
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Sponsor Type

Sponsor Type for Dinoprostone
Sponsor Trials
Other 54
Industry 8
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