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OC containing EE and NET

Phase 1

Arthritis | Small molecule | Musculoskeletal |Bristol-Myers Squibb Company|Last Updated: Dec 26, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

OC containing EE and NET · 1 trial · 1 indication

Phase 1 1
NCT02832180The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female SubjectsArthritis
COMPLETED25 Analytics
PHASE1COMPLETED
The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects
Arthritis
NCT0283218025
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)

Secondary Endpoints

Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Daily single dose of OC containing EE and NETEXPERIMENTALDaily single dose of OC Containing EE and NET alone.
Daily single dose of OC in combination with BMS-986142EXPERIMENTALDaily single dose of OC containing EE and NET in combination with BMS-986142.

Interventions

NameTypeDescription
OC containing EE and NETDRUG -
BMS-986142DRUG -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Signed Informed Consent * Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch...

Countries:United States
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Competitive Landscape -Arthritis 9 trials

CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH5PHASE4Undisclosed
Smith & Nephew plc Sponsored ADRSNN3PHASE4Undisclosed
Johnson & JohnsonJNJ1PHASE4Undisclosed
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Frequently asked questions about OC containing EE and NET

What is OC containing EE and NET used for?

OC containing EE and NET is an oral contraceptive containing ethinyl estradiol (EE) and norethindrone acetate (NET). In the context of the clinical trial, it was studied in healthy female subjects to assess its pharmacokinetics when combined with BMS-986142, an investigational drug for arthritis. The trial was completed with 25 participants.

Who makes OC containing EE and NET?

OC containing EE and NET is developed by Bristol-Myers Squibb Company (ticker: BMY). The company conducted a Phase 1 clinical trial to evaluate the effect of BMS-986142 on the pharmacokinetics of this combined oral contraceptive in healthy female subjects.

What phase is OC containing EE and NET in?

OC containing EE and NET is in Phase 1 clinical development. The completed trial, NCT02832180, was a Phase 1 study with 25 healthy female participants. The drug is investigational and not approved for any indication.

What clinical trials is OC containing EE and NET in?

OC containing EE and NET was studied in one completed Phase 1 clinical trial, NCT02832180, titled 'The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects.' The trial enrolled 25 participants in the United States.

Is OC containing EE and NET the same as ethinyl estradiol and norethindrone acetate?

Yes, OC containing EE and NET is the same as a combined oral contraceptive containing ethinyl estradiol (EE) and norethindrone acetate (NET). These are the active ingredients in the oral contraceptive studied in the clinical trial.