M0001 Effects on Oral Contraceptive Plasma Levels

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: prucalopride

• Registration Number: NCT01036893
• Lead Sponsor: Movetis

Brief Summary

This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.

The objectives of this phase I trial are to investigate in healthy female subjects:

* the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral contraceptives, after the first dose of prucalopride.

* the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state), on the pharmacokinetics of ethinylestradiol and norethisterone acetate.

This trial will be conducted in healthy females of child bearing potential, i.e. females aged between 18 and 45 years (pre-menopausal).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oral contraceptives with prucalopride	prucalopride	prucalopride

Primary Outcome Measures

Name	Time	Method
plasma levels oral contraceptives	first days
Plasma levels oral contraceptives after steady state	5 days

Trial Locations

Locations (1)

FOCUS GmbH; 🇩🇪 Neuss, Germany