Clinical Trials


Study of Combined Oral Contraceptive Effects in Female Subjects

This study has been completed
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare Identifier

First received: June 2, 2014
Last updated: April 13, 2018
Last Verified: April 2018
History of Changes


The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-955176
Drug : Ortho Cyclen
Phase 1

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 ViiV Healthcare:

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: 46
Study Start Date: June 2, 2014
Study Completion Date: August 25, 2014
Primary Completion Date: August 25, 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  
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

    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: NCT02157467

    Sponsors and Collaborators

    ViiV Healthcare


    Study Director: Viiv Clinical Trials ViiV Healthcare
    More Information

    More Information

    Responsible Party: ViiV Healthcare Identifier: NCT02157467   History of Changes  
    Other Study ID Numbers: 206293  
    Study First Received: June 2, 2014  
    Last Updated: April 13, 2018  

    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Norgestimate, ethinyl estradiol drug combination processed this data on July 10, 2020
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