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OpenTrials
Completed

NCT Number: NCT01063023

Drug Interaction Oral Contraceptive Pill (OCP)

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

Completed

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pra International

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ortho Tri-Cyclen®

Drug

Tablets, Oral, 1 Tablet, once daily

BMS-650032

Drug

Tablets, Oral, 600 mg, BID

Primary outcomes

  1. Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)

    Time frame: 24 hours of dosing

Secondary outcomes

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

    Time frame: Safety will be assessed through day 78

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2010
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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