The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ethinyl estradiol and levonorgestrel; exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254800

H8O-EW-GWBC

Details and patient eligibility

About

The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.
• Participation in a study involving administration of an investigational compound within the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Sequence 1

Experimental group

Description:

Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone

Treatment:

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Sequence 2

Experimental group

Description:

Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide

Treatment:

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Sequence 3

Experimental group

Description:

Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide

Treatment:

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide