Comparative Bioavailability Study of Two Misoprostol Formulations

Region Skane

Status and phase: Completed; Phase 1

Conditions: Labour, Induced

Treatments: Drug: Cytotec®; Drug: Angusta™

Study type: Interventional

Funder types: Other

Identifiers

NCT02516631

AZ-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Oral (A)

Active Comparator group

Description:

One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg).

Treatment:

Drug: Angusta™

Drug: Cytotec®

Drug: Angusta™

Drug: Cytotec®

Drug: Cytotec®

Drug: Angusta™

Oral (B)

Active Comparator group

Description:

Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®.

Treatment:

Drug: Angusta™

Drug: Cytotec®

Drug: Angusta™

Drug: Cytotec®

Drug: Cytotec®

Drug: Angusta™

Sublingual (C)

Active Comparator group

Description:

Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg.

Treatment:

Drug: Angusta™

Drug: Cytotec®

Drug: Angusta™

Drug: Cytotec®

Drug: Cytotec®

Drug: Angusta™