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Drug Interaction Oral Contraceptive Pill (OCP)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Hepatitis C Virus

Treatments

Drug: Ortho Tri-Cyclen®
Drug: BMS-650032

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063023
AI447-019

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

Arm A - Ortho Tri-Cyclen®
Active Comparator group
Description:
1 to 28 days
Treatment:
Drug: Ortho Tri-Cyclen®
Arm B - Ortho Tri-Cyclen®
Active Comparator group
Description:
29 to 56 days
Treatment:
Drug: Ortho Tri-Cyclen®
Arm C - Ortho Tri-Cyclen® + BMS-650032
Active Comparator group
Description:
Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days
Treatment:
Drug: BMS-650032
Drug: Ortho Tri-Cyclen®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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