A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

What Was Tested

The trial (phase 1) is built around 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.

It had two arms (groups): Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1) (experimental) and EE/NGM + Tirzepatide (Period 2) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: 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 used hormonal implants or received hormonal injections in the past 12 months.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Being open-label, the Tirzepatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-02-26 with completion listed for 2021-02-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE (time frame: 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) (time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Tirzepatide in 40 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page, all human trials.