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Clinical trial

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

ID
Name
17103
Description
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.
Trial arms
Trial start
2020-02-26
Estimated PCD
2021-02-09
Trial end
2021-02-09
Status
Completed
Phase
Early phase I
Treatment
Tirzepatide
Administered SC
Arms:
EE/NGM + Tirzepatide (Period 2)
Other names:
LY3298176
EE/NGM
Combination oral contraceptive administered orally
Arms:
EE/NGM + Tirzepatide (Period 2), Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)
Size
40
Primary endpoint
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)
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
Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE
Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)
Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)
Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-03-27

1 organization

2 products

1 indication

Product
Tirzepatide
Indication
Healthy
Product
EE/NGM
Organization
Eli Lilly and Company