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Completed

NCT Number: NCT01324505

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

This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme

Placebo

Drug

Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.

Microgyn®

Drug

Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.

Primary outcomes

  1. Area under the ethinylestradiol concentration-time curve

    Time frame: in the 24 hour dosing interval

  2. Area under the levonorgestrel concentration-time curve

    Time frame: in the 24 hour dosing interval

Secondary outcomes

  1. Maximum oral contraceptive concentration

    Time frame: in the 24 hour dosing interval

  2. Area under the semaglutide concentration-time curve

    Time frame: in the 24 hour dosing interval

  3. Maximum semaglutide concentration

    Time frame: within the weekly dosing interval

  4. Percentage of subjects experiencing adverse events

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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