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
NCT02832180 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2016-12-26
Summary
This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
Conditions
Interventions
- DRUG
-
OC containing EE and NET
- DRUG
-
BMS-986142
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
NCT05891262 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Combined Oral Contraceptive Effects in Female Subjects
NCT02157467 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
NCT04934696 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
NCT04016753 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women
NCT01953809 ·Status: WITHDRAWN ·Phase: PHASE1
-
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
NCT02103569 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00932321 ·Status: COMPLETED ·Phase: PHASE3
-
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
NCT02480881 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
NCT00212342 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
NCT02652650 ·Status: COMPLETED ·Phase: PHASE1
-
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
NCT00266032 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
NCT01250210 ·Status: COMPLETED ·Phase: PHASE2
-
AZD6140 Oral Contraceptive Interaction Study
NCT00685906 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
NCT00915174 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00391807 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
NCT02170038 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
NCT02159131 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
NCT02175394 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
NCT05294341 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants
NCT03249402 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol
NCT03547024 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Oral Contraceptive Pill (OCP)
NCT01063023 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers
NCT02245438 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
NCT01257984 ·Status: COMPLETED ·Phase: PHASE3
-
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
NCT05505162 ·Status: COMPLETED ·Phase: PHASE1