CompletedPhase 1

Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes

An Open-label, One-sequence Cross-over, Single Centre Trial Investigating the Influence of Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug After Multiple Dose Administration of Semaglutide in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18.5-35•HbA1c 6.5-10%•Female

Primary endpoints

•AUC of ethinylestradiol•AUC of levonorgestrel

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01324505

Org study IDNN9535-3819

Secondary ID2010-022435-11

Secondary IDU1111-1119-2214WHO

Timeline

Milestones

Study first posted2011-03-29estimated

Last update posted2017-02-08estimated

Study start2011-03 (month precision)

Primary completion2012-01actual (month precision)

Study completion2012-01actual (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained by a physician before any trial-related activities

•Postmenopausal women: a. With at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) above 40 mIU/mL and oestrogen deficiency (estradiol levels less than 30 pg/mL, or a negative gestagen test) or b. Bilateral oophorectomy (surgical removal of both ovaries)

•Type 2 diabetes treated with either diet and exercise alone or with metformin (monotherapy) having a glycosylated haemoglobin (HbA1c) of 6.5 -10% (both inclusive)

•Stable treatment of diabetes, either diet and exercise only or a stable dose level of metformin, for at least 3 months

•BMI (Body Mass Index) between 18.5 - 35.0 kg/m^2 (both inclusive)

Exclusion criteria

•Known or suspected hypersensitivity to trial products or related products

•Previous participation in this trial. Participation is defined as being dosed with either drug

•Treatment with antidiabetic drug other than metformin within the last 3 months

•Use of hormone replacement therapy within 4 weeks prior to starting dosing with the trial product

•Presence or history of cancer or any clinically significant diseases or disorders, considered by the physician to have influence on the results of this trial

•Subjects who are known to have hepatitis

•Positive human immunodeficiency virus (HIV) antibodies

•Uncontrolled treated/untreated hypertension (systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg)

•History of alcoholism or drug abuse during the last 3 months

•History of chronic or idiopathic acute pancreatitis

•Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (FMTC)

•Personal history of non-familial medullary thyroid carcinoma

•Subjects who are considered at increased risk of thrombosis formation, such as deep vein thrombosis, pulmonary embolism, infarction or apoplexy (as judged by the trial physician) and subjects who are smokers

•Blood or plasma donation within the last 3 months prior to first dosing

•Participation in any other trial investigating other products or involving blood sampling within the last 3 months prior to first dosing

•Inability or unwillingness to perform self-injection (with placebo medium) at trial start

Endpoints (6)

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

6 endpoints

Primary/protocol endpoint

Area under the ethinylestradiol concentration-time curve

Time frame:in the 24 hour dosing interval

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Area under the levonorgestrel concentration-time curve

Time frame:in the 24 hour dosing interval

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum oral contraceptive concentration

Time frame:in the 24 hour dosing interval

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the semaglutide concentration-time curve

Time frame:in the 24 hour dosing interval

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum semaglutide concentration

Time frame:within the weekly dosing interval

Cmax

concentration, descriptive

Secondary/protocol endpoint

Percentage of subjects experiencing adverse events

Time frame:from week 1 to end of trial at maximum 23 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.