Drug Interaction Oral Contraceptive Pill (OCP)

NCT ID: NCT01063023

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A - Ortho Tri-Cyclen®

1 to 28 days

Group Type ACTIVE_COMPARATOR

Ortho Tri-Cyclen®

Intervention Type DRUG

Tablets, Oral, 1 Tablet, once daily

Arm B - Ortho Tri-Cyclen®

29 to 56 days

Group Type ACTIVE_COMPARATOR

Ortho Tri-Cyclen®

Intervention Type DRUG

Tablets, Oral, 1 Tablet, once daily

Arm C - Ortho Tri-Cyclen® + BMS-650032

Ortho Tri-Cyclen®: 57 to 77 days

BMS-650032: 68 to 77 days

Group Type ACTIVE_COMPARATOR

Ortho Tri-Cyclen®

Intervention Type DRUG

Tablets, Oral, 1 Tablet, once daily

BMS-650032

Intervention Type DRUG

Tablets, Oral, 600 mg, BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ortho Tri-Cyclen®

Tablets, Oral, 1 Tablet, once daily

Intervention Type DRUG

BMS-650032

Tablets, Oral, 600 mg, BID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bristol-Myers Squibb

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pra International

Lenexa, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI447-019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Contraceptive Therapy and Sexuality
NCT02613039 COMPLETED PHASE4
Drug Interaction - Oral Contraceptive
NCT00399685 COMPLETED PHASE1
A Study of LY2216684 in Healthy Females
NCT01373931 COMPLETED PHASE1