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

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Phase 4

Completed

Conditions: Induced Abortion

Interventions: Drug: Mifepristone
Dietary Supplement: Placebo
Drug: Misoprostol

First Posted Date: 2015-04-09

Last Posted Date: 2022-03-02

Lead Sponsor: Medstar Health Research Institute

Target Recruit Count: 100

Registration Number: NCT02412618

Misoprostol Prior to Intrauterine Contraceptive Device Insertion

Phase 1

Completed

Conditions: Pain Prior to IUD Insertion

Interventions: Drug: Misoprostol
Drug: Placebo

First Posted Date: 2015-04-08

Last Posted Date: 2016-06-01

Lead Sponsor: Assiut University

Target Recruit Count: 140

Registration Number: NCT02412033

Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Phase 2

Completed

Conditions: Miscarriage

Interventions: Drug: Placebo
Drug: Letrozole
Drug: Misoprostol

First Posted Date: 2015-04-01

Last Posted Date: 2017-01-26

Lead Sponsor: Ain Shams University

Target Recruit Count: 400

Registration Number: NCT02405156

Locations: 🇪🇬
Ain Shams University, Cairo, Egypt

Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Phase 2

Completed

Conditions: Complete Miscarriage

Interventions: Drug: Letrozole
Other: Placebo
Drug: Misoprostol

First Posted Date: 2015-03-27

Last Posted Date: 2015-09-29

Lead Sponsor: Ain Shams University

Target Recruit Count: 423

Registration Number: NCT02401425

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

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Phase 4

Terminated

Conditions: Pregnancy
Missed Abortion

Interventions: Drug: Mifepristone
Drug: Misoprostol

First Posted Date: 2015-01-19

Last Posted Date: 2019-01-15

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 416

Registration Number: NCT02342002

Locations: 🇦🇷
Hospital Nacional Profesor Alejandro Posadas, Buenos Aires, Argentina
🇬🇦
CHU Libreville, Libreville, Gabon
🇲🇽
Hospital General Valle Ceylan, Tlalnepantla, Mexico

and more 1 locations