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Drug Interaction Oral Contraceptive Pill (OCP)

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: February 3, 2010
Last updated: January 24, 2011
Last verified: June 2010
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects

Condition Intervention Phase
Hepatitis C Virus Drug: Ortho Tri-Cyclen® Drug: BMS-650032 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered [ Time Frame: 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 ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01063023

United States, Kansas
Pra International
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01063023     History of Changes
Other Study ID Numbers: AI447-019
Study First Received: February 3, 2010
Last Updated: January 24, 2011

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 20, 2017