M0001 Effects on Oral Contraceptive Plasma Levels
|ClinicalTrials.gov Identifier: NCT01036893|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : May 17, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: prucalopride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||May 2010|
|No Intervention: oral contraceptives without prucalopride|
Active Comparator: oral contraceptives with prucalopride
prucalopride 2 mg oral dosing o.d. for 6 days
- plasma levels oral contraceptives [ Time Frame: first days ]
- Plasma levels oral contraceptives after steady state [ Time Frame: 5 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036893
|Neuss, Germany, D-41460|