A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
NCT05985590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2024-01-24
Summary
The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
BMS-986278
Specified dose on specified days
- DRUG
-
Drospirenone/Ethinyl Estradiol
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-18
- Primary Completion
- 2023-12-11
- Completion
- 2023-12-11
- FDA Drug
- Yes
Countries
- Canada
Study Locations
More Related Trials
-
The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
NCT03262740 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
NCT03126097 ·Status: TERMINATED ·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
-
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
NCT02957630 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin®
NCT06233058 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Study of Combined Oral Contraceptive Effects in Female Subjects
NCT02157467 ·Status: COMPLETED ·Phase: PHASE1
-
Endometrial Safety Study
NCT00522873 ·Status: COMPLETED ·Phase: PHASE3
-
Cycle Control and Safety of E2-DRSP
NCT00653614 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00391807 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.
NCT00367276 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
NCT00461305 ·Status: COMPLETED ·Phase: PHASE2/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
-
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
NCT00511797 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
NCT00631124 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
NCT07215806 ·Status: COMPLETED ·Phase: PHASE1
-
AZD6140 Oral Contraceptive Interaction Study
NCT00685906 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
NCT05934942 ·Status: TERMINATED ·Phase: PHASE1
-
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood
NCT05613777 ·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
-
Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®
NCT06233071 ·Status: RECRUITING ·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
-
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
NCT02480881 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
NCT01892904 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
NCT00567164 ·Status: COMPLETED ·Phase: PHASE3