NCT02516631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

June 12, 2015

Last Update Submit

December 5, 2016

Conditions

Labour, Induced

Keywords

Labour, inducedMisoprostolPharmacokineticsCardiotocographySafety

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

  • Cardiotochographic (CTG) monitoring.

    During labour

  • Adverse event / Serious Adverse event profile.

    From screening and until 7 days post treatment.

Study Arms (3)

Oral (A)

ACTIVE COMPARATOR

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

Drug: Angusta™Drug: Cytotec®

Oral (B)

ACTIVE COMPARATOR

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

Drug: Angusta™Drug: Cytotec®

Sublingual (C)

ACTIVE COMPARATOR

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

Drug: Angusta™Drug: Cytotec®

Interventions

Angusta™DRUG

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

Oral (A)
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.

Oral (A)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital Lund

Lund, Sweden

Location

Related Publications (1)

  • Amini M, Reis M, Wide-Swensson D. A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration. Front Pharmacol. 2020 Feb 12;11:50. doi: 10.3389/fphar.2020.00050. eCollection 2020.

    PMID: 32116725DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Dag Wide-Swensson

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

August 6, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

SE(1)