A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

What Was Tested

This registered phase 1 trial tested Dulaglutide.

The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body.

Information about any side effects that may occur will also be collected.

It had 1 arm (groups): Ortho-Cyclen (OC) Alone (Period 1); OC+Dulaglutide (Period 2) (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

The registry lists 22 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: Are females of child-bearing potential, and who are overtly healthy as determined by medical history and physical examination. Have a body mass index (BMI) of between 18.5 and 30.0 kilogram-meter squared (kg/m\^2), at screening. Have venous access sufficient to allow for blood sampling. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and restrictions.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: have known allergies to ortho-cyclen, dulaglutide, or to related compounds or to any components of either formulation; have family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc; regularly use known drugs of abuse and/or show positive findings on urinary drug screening.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Dulaglutide study: the participants and staff both knew the treatment.

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

It started in 2011-10 with completion listed for 2012-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Dulaglutide in 22 people.

Its size is small, so on its own it can only give an early look.

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

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