AZD6140 Oral Contraceptive Interaction Study

NCT00685906 | Completed Phase 1

• 2 other identifiers: D5130C00042AZD6140/OC Study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.

Conditions

Healthy

Keywords

oral contraceptive; birth control; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®

  At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.

Secondary Outcomes (3)

• Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®

  At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.

• Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®

  At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.

• Safety and tolerability of AZD6140 when co-administered with Nordette®

  Screening through completion of the study

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD6140

2

ACTIVE COMPARATOR

Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)

Interventions

AZD6140 DRUG

90 mg tablet taken by mouth 2 times a day for 21 days per cycle

1

Levonorgestrel and Ethinyl Estradiol (Nordette®) DRUG

1 tablet taken by mouth once a day for 28 days per cycle

Also known as: Nordette®

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
• Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
• Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide

You may not qualify if:

• History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
• History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
• History or presence of significant medical problems
• Women who are current smokers

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Miami, Florida, United States

Location

MeSH Terms

Interventions

Ticagrelor; Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kathleen Butler, MD

  AstraZeneca

  STUDY DIRECTOR

• Audrey, Martinez, MD

  SeaView Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 29, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 2, 2010

Record last verified: 2010-12

Locations

US (1)