Study S001514

A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06039826
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 46
Start: 2023-09-12
Primary completion: 2024-07-11
Lead sponsor: Eli Lilly and Company
Conditions: Overweight
Interventions: DRUG:LY3437943; DRUG:Ethinyl Estradiol; DRUG:Drospirenone
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J1I-MC-GZBV

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol [Predose on Day 1 up to 144 days postdose]
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol [Predose on Day 1 up to 144 days postdose]
PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol [Predose on Day 1 up to 144 days postdose]
PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone [Predose on Day 1 up to 144 days postdose]
PK: Maximum Observed Concentration (Cmax) of Drospirenone [Predose on Day 1 up to 144 days postdose]
PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone [Predose on Day 1 up to 144 days postdose]

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