Comparative Bioavailability Study of Two Misoprostol Formulations

Labour, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516631
• Other study ID #: AZ-201
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2015
• Last updated: December 5, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult females

• Women wanting to participate and having given informed consent

• Known to have reached week 37 + 0 days to week 42 + 2 days of gestation

• With a viable fetus in a vertex position

• Age above or equal to 18 years old

• Women opting for vaginal delivery

• BMI between 20 and 30 kg/m2

Exclusion Criteria:

• Women with known allergy to misoprostol or other prostaglandins

• Women with prior caesarean section

• Women with dead or anomalous fetus

• Women with twin pregnancy

• Women with known liver or renal dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labour, Induced

Intervention

Drug:
• Angusta™
One tablet of Angusta™ (25 µg) given every 2 hours
• 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.
• Angusta™
Two tablets of Angusta™ 25 µg given every 4 hours
• Cytotec®
¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
• Angusta™
Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
• 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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital Lund	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the curve) 0-t misoprostol		For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose	No
Primary	AUC (area under the curve) 0-inf of misoprostol		For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose	No
Secondary	t max (Time to maximum) of misoprostol		For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose	No
Secondary	t 1/2 (Elimination half-life) of misoprostol		For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose	No
Secondary	APGAR score of infant		At time of birth	Yes
Secondary	Cardiotochographic (CTG) monitoring.		During labour	Yes
Secondary	Adverse event / Serious Adverse event profile.		From screening and until 7 days post treatment.	Yes