M0001 Effects on Oral Contraceptive Plasma Levels

This study has been completed.
Sponsor:
Collaborator:
FOCUS GmbH
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT01036893
First received: December 18, 2009
Last updated: May 16, 2011
Last verified: June 2010
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: prucalopride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects

Further study details as provided by Movetis:

Primary Outcome Measures:
  • plasma levels oral contraceptives [ Time Frame: first days ] [ Designated as safety issue: No ]
  • Plasma levels oral contraceptives after steady state [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: oral contraceptives without prucalopride
Active Comparator: oral contraceptives with prucalopride
prucalopride
Drug: prucalopride
prucalopride 2 mg oral dosing o.d. for 6 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

Subjects who meet all of the following criteria are eligible for this trial:

  1. Healthy females, aged between 18 and 45 years extremes included, who have regular menstrual cycle of 28 ± 3 days for the last 6 months.
  2. Adequate use of non-hormonal birth control (double-barrier method (e.g. condom and spermicide, cervical cap and spermicide) or sterilization or vasectomy of the partner or certified abstinence).
  3. Subjects are not smoking for at least 6 months prior to selection.
  4. A body mass index (BMI) between 18 and 27 kg/m2, extremes included.
  5. The subject is in good health based on a pre-trial physical and gynaecological examination, medical history, anamnesis, electrocardiogram (ECG) and the results of biochemistry, coagulation or haematology tests or a urinalysis carried out within 4 weeks before the start of the trial. If the results of the biochemistry, coagulation or haematology tests or the urinalysis are not within the laboratory's reference ranges the subject will be included only on condition that the investigator judges that the deviations are not clinically significant.
  6. Subjects voluntarily signed written Informed Consent Form (ICF) in accordance with the regional laws or regulations, prior to the first trial related activity, indicating an understanding of the purpose of this trial.
  7. Subjects are willing to adhere to the treatment regimen and trial procedures described in this protocol.

Exclusion criteria

Subjects meeting any of the following criteria will be excluded from the trial:

  1. History, evidence or suspicion of alcohol or drug abuse (screening and Day -1).
  2. History or evidence of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), hepatic or gastrointestinal, renal or endocrine (diabetes mellitus, thyrotoxicosis), or neurological (Parkinsonism) or psychiatric, gynaecological or dermatological disease, drug allergy.
  3. Clinical significant abnormal ECG-intervals of morphology of the ECG, QT >500 ms or QTcB>470 ms.
  4. Use of concomitant medication or oral contraceptives within 6 weeks prior to screening, or any hormonal depot-device within 6 months prior to screening . All medication, with the exception of paracetamol should be stopped.
  5. Participation in an investigational drug trial in 30 days prior to the first visit.
  6. Donation of blood in the 60 days preceding the first visit.
  7. Pregnancy (as confirmed by a HCG test during screening and at Day 1 of each treatment session before dosing) or breast feeding.
  8. Subjects with positive results for HIV, hepatitis B or C at screening.
  9. Known allergy to the trial drugs ingredients/excipients.
  10. Subject has contraindications for the use of oral contraceptives (known or suspected active venous thrombo-embolic disorder, known or suspected hormone dependent malignancies, undiagnosed vaginal bleeding, coagulation disorders, menstrual cycle depending migraine, lipid metabolism disorders, hepatic disorders)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036893

Locations
Germany
FOCUS GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Movetis
FOCUS GmbH
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Remi Van Den Broeck, Chief Development Officer, Movetis
ClinicalTrials.gov Identifier: NCT01036893     History of Changes
Other Study ID Numbers: M0001-C101
Study First Received: December 18, 2009
Last Updated: May 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 26, 2014