DelfaGLP-1 Atlas

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CompletedPhase 1

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

38

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-35•Female

Primary endpoint

•Assessment of Pharmacokinetics profile of exenatide (AUC₀–∞, Cmax)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00254800
Org study IDH8O-EW-GWBC

Timeline

Milestones

Study first posted2005-11-17estimated
Last update posted2015-08-18estimated
Study start2005-11 (month precision)
Primary completion2006-08actual (month precision)
Study completion2006-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

•Pre-menopausal female of child-bearing potential.
•Body Mass Index (BMI) between 19 and 35 kg/m^2, inclusive.

Exclusion criteria

•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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Time frame:Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48

AUC₀–∞

concentration, descriptive

componentsAUC₀–∞, Cmax

Secondary/protocol endpoint

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Time frame:Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.

Time frame:Baseline through Day 84

Treatment-emergent AEs (any)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.