Phase 1
Completed N=40
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
Healthy
Source: ClinicalTrials.gov NCT04172987 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: 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) — 966; 811 picogram hour per milliliter (pg*h/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
966; 811 | — |
| PRIMARY Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE |
119; 49.6 | — |
| PRIMARY Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN) |
19900; 14600 | — |
| PRIMARY Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN) |
2070; 892 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy females as determined by medical history, physical examination, and other screening procedures
- Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening
- Are not intending to start a family within 2 months after the study
Exclusion Criteria
- Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds
- Have a medical condition or medical history that precludes the taking of combined oral contraceptives
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
- Have used hormonal implants or received hormonal injections in the past 12 months
- Unwilling to comply with smoking restrictions during the study
- Is a known user of drugs of abuse
Data sourced from ClinicalTrials.gov (NCT04172987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.