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Drug Interaction Oral Contraceptive Pill (OCP)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus

Intervention: Ortho Tri-Cyclen® (Drug); BMS-650032 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)

Secondary outcome:

To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered

To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.


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

Locations and Contacts

Pra International, Lenexa, Kansas 66219, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: January 2010
Last updated: January 24, 2011

Page last updated: August 23, 2015

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