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The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
Plain-language guide to NCT00254800: phase 1 randomized trial of Exenatide, 38 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00254800
- Phase
- phase 1
- Status
- completed
- Start
- 2005-11
- Completion (planned or actual)
- 2006-08
- Participants
- 38 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Exenatide.
It had three arms (groups): Sequence 1 (experimental), Sequence 2 (experimental) and Sequence 3 (experimental).
Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone.
Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide.
Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide.
The registry classes the interventions as drug.
Who Took Part
The registry lists 38 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: Pre-menopausal female of child-bearing potential. Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive.
The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: on implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study; evidence of diabetes mellitus; participation in a study involving administration of an investigational compound within the past 3 months.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
It started in 2005-11 with completion listed for 2006-08.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Exenatide in 38 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.