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Study of Combined Oral Contraceptive Effects in Female Subjects

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: June 2, 2014
Last updated: May 13, 2016
Last verified: May 2016
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.

Condition Intervention Phase
Drug: BMS-955176
Drug: Ortho Cyclen
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Coadministration of BMS-955176 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Female Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination [ Time Frame: Before dosing (0 hour) through 24 hours after administration on Days 21 and 49 ]

Secondary Outcome Measures:
  • Serum progesterone measurements [ Time Frame: Day 14, 21, 35, and 42 ]
  • Trough blood samples collected for BMS-955716 [ Time Frame: Days 48, 49, 50 ]
  • Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: Two to three months ]

Enrollment: 22
Study Start Date: June 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: NGMN/EE + BMS-955176

Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28

Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days)

Drug: BMS-955176 Drug: Ortho Cyclen


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Signed Written Informed Consent a) The signed informed consent form
  2. Target population

    • a) Healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
    • b) Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive, at screening and Day -1. BMI = weight (kg)/[height (m)]2
    • c) Weight greater than or equal to 45 kg
    • d) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). If reenrolled, the subject must be reconsented
  3. Age and Reproductive Status

    • a) Women, 18 to 40 years of age, inclusive
    • b) Women of childbearing potential (WOCBP) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of Ortho Cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing EE for at least two months prior to dosing on Day 1 of Cycle 1 and willing to switch to Ortho Cyclen for the total duration of the study (approximately 78 days)
    • c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on Day 1 of Cycle 1
    • d) Women must not be breastfeeding

Exclusion Criteria:

Medical History and Concurrent Diseases

  • a) Any significant acute or chronic medical illness
  • b) History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
  • c) Current or recent (within 3 months of dosing on Day 1 of Cycle 1) gastrointestinal disease
  • d) Any major surgery within 4 weeks of dosing on Day 1 of Cycle 1
  • e) Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
  • f) Donation of > 400 mL to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on Day 1 of Cycle 1
  • g) Blood transfusion within 4 weeks of dosing on Day 1 of Cycle 1
  • h) Inability to tolerate oral medication
  • i) Inability to be venipunctured and/or tolerate venous access
  • j) Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1 of Cycle 1)
  • k) Recent (within 6 months of dosing on Day 1 of Cycle 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
  • l) Any other sound medical, psychiatric, and/or social reason as determined by the investigator
  Contacts and Locations
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Please refer to this study by its identifier: NCT02157467

Sponsors and Collaborators
Bristol-Myers Squibb
Principal Investigator: Robert A Feldman, MD MRA Clinical Research & Miami Research Associates
  More Information

Responsible Party: Bristol-Myers Squibb Identifier: NCT02157467     History of Changes
Other Study ID Numbers: AI468-041
Study First Received: June 2, 2014
Last Updated: May 13, 2016

Additional relevant MeSH terms:
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
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 April 25, 2017