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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR CYTOTEC

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Clinical Trials for Cytotec

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.
NCT00141895 A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death Terminated 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. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. 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 second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00256009 Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment Unknown status Rigshospitalet, Denmark Phase 4 A randomize trial: expectation or evacuatio uteri for the treatment after late abortion
NCT00426491 Misoprostol for Non-Viable Pregnancies Completed Madigan Army Medical Center Phase 3 The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.
NCT00576706 PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity Completed Korea Otsuka Pharmaceutical Co., Ltd. Phase 3 To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
NCT00674232 Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment Completed Gynuity Health Projects N/A This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.
NCT00771511 Cervical Capsaicin for Labor Induction and Pain Relief Withdrawn Columbia University Phase 4 In the setting of fetal demise it is important to help the mother deliver the fetus expeditiously and with as little physical trauma as possible. We hypothesize that application of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers such that delivery is less painful.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cytotec

Condition Name

Condition Name for Cytotec
Intervention Trials
Labor Induction 3
Pregnancy 3
Abortion, Second Trimester 2
Abortion, Induced 2
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Condition MeSH

Condition MeSH for Cytotec
Intervention Trials
Hemorrhage 5
Abortion, Incomplete 2
Postpartum Hemorrhage 2
Labor Pain 1
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Clinical Trial Locations for Cytotec

Trials by Country

Trials by Country for Cytotec
Location Trials
United States 8
Egypt 4
Turkey 2
Lebanon 2
Korea, Republic of 2
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Trials by US State

Trials by US State for Cytotec
Location Trials
Tennessee 2
Virginia 1
Texas 1
Missouri 1
Indiana 1
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Clinical Trial Progress for Cytotec

Clinical Trial Phase

Clinical Trial Phase for Cytotec
Clinical Trial Phase Trials
Phase 4 16
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cytotec
Clinical Trial Phase Trials
Completed 12
Recruiting 11
Not yet recruiting 5
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Clinical Trial Sponsors for Cytotec

Sponsor Name

Sponsor Name for Cytotec
Sponsor Trials
Gynuity Health Projects 5
Ain Shams Maternity Hospital 2
Vanderbilt University 2
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Sponsor Type

Sponsor Type for Cytotec
Sponsor Trials
Other 48
Industry 2
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Harvard Business School
Federal Trade Commission
Boehringer Ingelheim
Julphar
Cerilliant
AstraZeneca
Teva

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