DelfaGLP-1 Atlas

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CompletedPhase 1

Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women

A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

21

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-30•Female

Primary endpoints

•AUC of ethinylestradiol•AUC of levonorgestrel

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 IDNCT01508858
Org study IDNN2211-1330
Secondary ID2006-003904-21

Timeline

Milestones

Study first posted2012-01-12estimated
Last update posted2017-01-24estimated
Study start2006-11 (month precision)
Primary completion2007-04actual (month precision)
Study completion2007-04actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Postmenopausal woman
•Body Mass Index (BMI) between 18.0-30.0 kg/m^2 (both inclusive)
•Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments

Exclusion criteria

•History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
•Impaired renal function
•Active hepatitis B and/or active hepatitis C
•Positive HIV (human immunodeficiency virus) antibodies
•Known or suspected allergy to trial products or related products
•Pregnant or positive pregnancy test at screening or nursing mother
•Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
•Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
•History of alcoholism or drug abuse
•Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
•Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
•Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Endpoints (7)

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

7 endpoints
Primary/protocol endpoint

AUC of ethinylestradiol

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC of levonorgestrel

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC (0-t)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

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.