A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
NCT06783192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-01-20
Summary
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Conditions
- Human Immunodeficiency Virus (HIV)
- HIV Pre-Exposure Prophylaxis
Interventions
- DRUG
-
MK-8527
MK-8527 capsule taken by mouth
- DRUG
-
LNG/EE
LNG/EE combination tablet taken by mouth.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-14
- Primary Completion
- 2023-10-11
- Completion
- 2023-10-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
AZD6140 Oral Contraceptive Interaction Study
NCT00685906 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
NCT02182791 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
NCT00245921 ·Status: COMPLETED ·Phase: PHASE3
-
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants
NCT06310616 ·Status: COMPLETED ·Phase: PHASE1
-
Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics
NCT02531321 ·Status: TERMINATED ·Phase: PHASE4
-
Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
NCT01250210 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
NCT01709318 ·Status: COMPLETED ·Phase: PHASE2
-
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
NCT03324685 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
NCT01597986 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00477633 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
NCT01181479 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
NCT01667978 ·Status: COMPLETED ·Phase: NA
-
Study of Combined Oral Contraceptive Effects in Female Subjects
NCT02157467 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of an Oral Contraceptive
NCT00932321 ·Status: COMPLETED ·Phase: PHASE3
-
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
NCT05064332 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Oral Contraceptive Pill (OCP)
NCT01063023 ·Status: COMPLETED ·Phase: PHASE1
-
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
NCT00739622 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
NCT05139121 ·Status: COMPLETED ·Phase: PHASE3
-
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
NCT03608241 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants
NCT05579574 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
NCT01110525 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
NCT00248963 ·Status: COMPLETED ·Phase: PHASE3