Contraception
Conditions
Brief summary
Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 to 35 years. * Healthy as determined by the investigator on the basis of medical history and screening evaluations. * Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.
Exclusion criteria
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article. * Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy. * Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics | — |
Secondary
| Measure | Time frame |
|---|---|
| To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women | — |
Outcome results
None listed