Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01508858
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
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Purpose
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: liraglutide Drug: placebo Drug: levonorgestrel / ethinylestradiol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- AUC of ethinylestradiol [ Designated as safety issue: No ]
- AUC of levonorgestrel [ Designated as safety issue: No ]
Secondary Outcome Measures:
- AUC (0-t) [ Designated as safety issue: No ]
- Cmax, maximum concentration [ Designated as safety issue: No ]
- tmax, time to reach Cmax [ Designated as safety issue: No ]
- t½, terminal half-life [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment period 1 |
Drug: liraglutide
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
Drug: placebo
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
Drug: levonorgestrel / ethinylestradiol
One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
|
| Placebo Comparator: Treatment period 2 |
Drug: liraglutide
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
Drug: placebo
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
Drug: levonorgestrel / ethinylestradiol
One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01508858 History of Changes |
| Other Study ID Numbers: | NN2211-1330, 2006-003904-21 |
| Study First Received: | January 9, 2012 |
| Last Updated: | January 9, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Contraceptive Agents Levonorgestrel Contraceptives, Oral Ethinyl Estradiol Glucagon-Like Peptide 1 |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Incretins |
ClinicalTrials.gov processed this record on May 23, 2013