Drug Interaction Oral Contraceptive Pill (OCP)

January 24, 2011 updated by: Bristol-Myers Squibb

Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects

To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • PRA International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug

Exclusion Criteria:

  • Abnormal pap smear within 1 year prior to day 1
  • Any significant or chronic uncontrolled medical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A - Ortho Tri-Cyclen®
1 to 28 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Active Comparator: Arm B - Ortho Tri-Cyclen®
29 to 56 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Active Comparator: Arm C - Ortho Tri-Cyclen® + BMS-650032

Ortho Tri-Cyclen®: 57 to 77 days

BMS-650032: 68 to 77 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Drug: BMS-650032
Tablets, Oral, 600 mg, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
Time Frame: 24 hours of dosing
24 hours of dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
Time Frame: Safety will be assessed through day 78
Safety will be assessed through day 78
To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
Time Frame: PK assessments will be done on Day 49, 50, 77 and 78
PK assessments will be done on Day 49, 50, 77 and 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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