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ethinyl estradiol and levonorgestrel; exenatide · 1 trial · 1 indication
To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone |
| Sequence 2 | EXPERIMENTAL | Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide |
| Sequence 3 | EXPERIMENTAL | Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide |
| Name | Type | Description |
|---|---|---|
| ethinyl estradiol and levonorgestrel; exenatide | DRUG | Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily |
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. * P...
Ethinyl estradiol and levonorgestrel; exenatide is being studied for use in Type 2 Diabetes Mellitus. It is a combination of an oral contraceptive (ethinyl estradiol and levonorgestrel) and exenatide, a medication for diabetes. The drug is in Phase 1 clinical development as a small molecule therapy.
The specific molecular target of ethinyl estradiol and levonorgestrel; exenatide is not disclosed in available information. The drug combines an oral contraceptive with exenatide, which is known to affect glucose metabolism, but the precise target for this combination has not been specified.
AstraZeneca PLC (ticker: AZN) is developing ethinyl estradiol and levonorgestrel; exenatide. The company is conducting clinical research on this combination therapy for Type 2 Diabetes Mellitus.
Ethinyl estradiol and levonorgestrel; exenatide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Ethinyl estradiol and levonorgestrel; exenatide has one completed clinical trial, NCT00254800, titled 'The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females.' This Phase 1 study enrolled 38 healthy female participants in the United Kingdom and was completed.
Yes, ethinyl estradiol and levonorgestrel; exenatide is also known as Ethinyl estradiol/Levonorgestrel (EE/LEVO) and Ethinyl estradiol/Levonorgestrel. These names refer to the same combination product being developed by AstraZeneca.