NCT02516631

Comparative Bioavailability Study of Two Misoprostol Formulations

A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following Single Oral or Sublingual Administration and Comparison of Safety of the Two Formulations Following Repeat Dosing Until Labour

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.

Detailed description

Prostaglandin E2 (dinoprostone) given vaginally or intra-cervically, and oxytocin have been the most commonly used preparations for induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. Misoprostol has anti-secretory and mucosal protective properties and was originally developed in the 1970s for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers. It is now used much more widely for 'off-label' indications like medication abortion, medical management of miscarriage, cervical ripening before surgical procedures, treatment of postpartum hemorrhage, and induction of labour. The lack of a specific license for Cytotec® to be used in obstetrics and gynecology has led to a number of problems regarding correct dose and dose regime. The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour. The drug shall be administered orally or sublingually.

Conditions

• Labour, Induced

Interventions

Type	Name	Description
DRUG	Angusta™	One tablet of Angusta™ (25 µg) given every 2 hours
DRUG	Cytotec®	1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced.
DRUG	Angusta™	Two tablets of Angusta™ 25 µg given every 4 hours
DRUG	Cytotec®	¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
DRUG	Angusta™	Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
DRUG	Cytotec®	¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2015-08-06
• Last updated: 2016-12-06

Locations

1 site across 1 country: Sweden