Misoprostol

Generic Name: Misoprostol

Brand Names: Arthrotec, Cytotec, Mifegymiso

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₃₈O_₅

CAS Number: 59122-46-2

Unique Ingredient Identifier: 0E43V0BB57

Background: Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions. The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone.

Misoprostol was granted FDA approval on 27 December 1988.

Indication: Misoprostol is indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients. Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers. Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.

Associated Conditions: Gastric Ulcer, Incomplete Abortion, Missed Abortion, Postpartum Haemorrhage (PPH)

Associated Therapies: Induction of cervix ripening therapy, Medically induced abortion

Clinical Trials

Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Phase 2

Completed

Conditions: Postpartum Hemorrhage

Interventions: Other: Placebo
Drug: Misoprostol

First Posted Date: 2014-03-11

Last Posted Date: 2015-12-22

Lead Sponsor: Ain Shams University

Target Recruit Count: 636

Registration Number: NCT02083107

Locations: 🇪🇬
Ain Shams University Maternity Hospital, Cairo, Egypt

Impact of Misoprostol on Blood Loss In Myomectomy Operations

Phase 3

Completed

Conditions: Leiomyoma

Interventions: Drug: Placebo( for misoprostol)
Drug: Misoprostol

First Posted Date: 2014-02-13

Last Posted Date: 2014-08-12

Lead Sponsor: Ain Shams University

Target Recruit Count: 50

Registration Number: NCT02061657

Locations: 🇪🇬
Ain Shams University, Maternity Hospital, Cairo, Egypt

The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

Phase 3

Completed

Conditions: Postpartum Hemorrhage

Interventions: Drug: Syntocinon
Drug: Carbetocin
Drug: Misoprostol

First Posted Date: 2014-02-04

Last Posted Date: 2014-02-06

Lead Sponsor: Ain Shams University

Target Recruit Count: 270

Registration Number: NCT02053922

Locations: 🇪🇬
Ain Shams Maternity Hospital, Cairo, Egypt

Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

Not Applicable

Conditions: Other Abortion

Interventions: Drug: Cytotec

First Posted Date: 2013-12-17

Last Posted Date: 2013-12-17

Lead Sponsor: Rambam Health Care Campus

Target Recruit Count: 100

Registration Number: NCT02013960

Locations: 🇮🇱
Rambam Health Campus, Haifa, Israel

Comparative Effectiveness of Pregnancy Failure Management Regimens

Phase 3

Completed

Conditions: Spontaneous Abortion

Interventions: Drug: Misoprostol
Drug: Mifepristone

First Posted Date: 2013-12-16

Last Posted Date: 2019-07-18

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 300

Registration Number: NCT02012491

Locations: 🇺🇸
University of California, Davis Medical Center, Sacramento, California, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Montefiore Medical Center, Bronx, New York, United States

Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding

Phase 2

Completed

Conditions: Ulcer Hemorrhage

Interventions: Drug: Placebo
Drug: Misoprostol

First Posted Date: 2013-12-02

Last Posted Date: 2019-01-31

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 82

Registration Number: NCT01998776

Locations: 🇯🇵
Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan
🇨🇳
Prince of Wales Hospital, Hong Kong, China