A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Oral Contraceptives

Treatments: Drug: Placebo AZD1981; Drug: Neovletta 21/28; Drug: AZD1981

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110525

2010-018864-18 (EudraCT Number)

D9830C00015

Details and patient eligibility

About

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females of childbearing potential
• Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
• Willing to use a highly effective method of birth control, ie, double barrier method contraception.

Exclusion criteria

• Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
• Any clinically significant disease or disorder.
• Any clinically relevant abnormal findings in physical examination.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD1981 + Oral contraceptive

Treatment:

Drug: Neovletta 21/28

Drug: AZD1981

2

Placebo Comparator group

Description:

Placebo + Oral contraceptive

Treatment:

Drug: Neovletta 21/28

Drug: Placebo AZD1981