Healthy
Conditions
Brief summary
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
Interventions
DRUGSeasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
1 tablet daily
DRUGSeasonique (LNG/EE and EE)
1 tablet daily
DRUGPortia (LNG/EE)
1 tablet daily x 28 days
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Premenopausal * Not pregnant or breastfeeding * Weight \<200 lbs * Currently taking oral contraceptives in the standard 28-day regimen for at least two months
Exclusion criteria
* Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) | Before, during and after the 7-day hormone free interval or EE-supplemented interval |
Secondary
| Measure | Time frame |
|---|---|
| Compare the differences in hormone withdrawal symptoms | Before, during and after the 7-day hormone free interval or EE-supplemented interval |
| Compare differences in ovarian follicular development | Before, during and after the 7-day hormone free interval or EE-supplemented intervals |
Countries
United States
Outcome results
None listed