Comparative Bioavailability Study of Two Misoprostol Formulations
- Registration Number
- NCT02516631
- Lead Sponsor
- Region Skane
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral (A) Cytotec® One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg). Oral (B) Cytotec® Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®. Sublingual (C) Cytotec® Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg. Oral (A) Angusta™ One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg). Oral (B) Angusta™ Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®. Sublingual (C) Angusta™ Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg.
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method 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 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 APGAR score of infant At time of birth Adverse event / Serious Adverse event profile. From screening and until 7 days post treatment. Cardiotochographic (CTG) monitoring. During labour
Trial Locations
- Locations (1)
Skåne University Hospital Lund
🇸🇪Lund, Sweden