Drug Interaction Oral Contraceptive Pill (OCP)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063023

Enrollment

Registered

2010-02-05

Start date

2010-01-31

Completion date

2010-06-30

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

Brief summary

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

Interventions

DRUGOrtho Tri-Cyclen®

Tablets, Oral, 1 Tablet, once daily

DRUGBMS-650032

Tablets, Oral, 600 mg, BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026