A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Mestranol; Norethindrone; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl

Criteria

Inclusion Criteria:

• healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.

• able to take a specific oral contraceptive & KG2107494.

• female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.

• female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.

Exclusion Criteria:

• pregnant or a nursing female.

• female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.

• Have suffered with certain infection within 4 weeks prior to the first dose of study drug