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Completed

NCT Number: NCT02516631

Comparative Bioavailability Study of Two Misoprostol Formulations

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.

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Key information

Conditions

Labour, Induced

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Skåne University Hospital Lund

Lund, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angusta™

Drug

One tablet of Angusta™ (25 µg) given every 2 hours

Cytotec®

Drug

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.

Primary outcomes

  1. AUC (area under the curve) 0-t misoprostol

    Time frame: 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

  2. AUC (area under the curve) 0-inf of misoprostol

    Time frame: 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

Secondary outcomes

  1. t max (Time to maximum) of misoprostol

    Time frame: 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

  2. t 1/2 (Elimination half-life) of misoprostol

    Time frame: 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

  3. APGAR score of infant

    Time frame: At time of birth

  4. Cardiotochographic (CTG) monitoring.

    Time frame: During labour

  5. Adverse event / Serious Adverse event profile.

    Time frame: From screening and until 7 days post treatment.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 6, 2015
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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