Adults 18 to 45, female only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)Primary· Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Ethinylestradiol (EE)
Group
Value
95% CI
OC (0.035 mg EE and 0.25 mg NGM)
966
± 40
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide
811
± 41
Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EEPrimary· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Cmax of EE
Group
Value
95% CI
OC (0.035 mg EE and 0.25 mg NGM)
119
± 33
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide
49.6
± 63
Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)Primary· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Norelgestromin (NGMN)
Group
Value
95% CI
OC (0.035 mg EE and 0.25 mg NGM)
19900
± 27
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide
14600
± 67
Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)Primary· Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Cmax of Norelgestromin (NGMN)
Group
Value
95% CI
OC (0.035 mg EE and 0.25 mg NGM)
2070
± 27
OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide
892
± 74
Adverse events — posted to ClinicalTrials.gov
Time frame: Lead-In Up To 15 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lead-in: OC ( 0.035 mg EE and 0.25 mg NGM)
Serious: 0/40 (0%)
Deaths: 0/40
Period 1: OC ( 0.035 mg EE and 0.25 mg NGM)
Serious: 0/38 (0%)
Deaths: 0/38
Period 2: OC ( 0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide
The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 27 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04172987.