Birth Control Pill Study
The Women's Health Clinical Research Center at University of Pennsylvania is currently recruiting healthy women who have regular periods for a research study of an investigational birth control pill. The birth control pill, LPRI-424, being used in this research study is investigational. An "investigational" drug is an experimental drug that has not yet been approved by the Food and Drug Administration (FDA) to be sold in the United States. LPRI-424 is currently being developed by Chemo Research S.L. to prevent pregnancy. LPRI 424 is a combined birth control pill that contains two types of hormones: progestin (dienogest 2 mg) and estrogen (0.02 mg ethinyl estradiol). It works by stopping a woman's egg from fully developing each month. The egg cannot accept a sperm and fertilization is prevented.
The difference of LPRI-424 from the birth control pills with similar hormones already available by prescription:
LPRI-424 has a lower dose of estrogen. It is expected that this would reduce the number and / or intensity of side effects.
It is designed as an extended-release tablet. Extended-release drugs release the active ingredients slowly and work for a longer time. This helps to reduce daily changes of hormone levels in the blood.
The purpose of this research is to test how well the birth control pill LPRI-424 works to prevent pregnancy and which side effects it causes.
If you agree to participate in the study, you will take part in this research for about 13.5 months. During this time, you will use the study drug for twelve months (13 drug cycles of 28 days) and you will visit the clinic 9 times. In addition, the study doctor or staff will contact you by phone at least 14 times including once a month.
If you are interested in participating in this study, complete the online pre-screener here or contact 215.662.7727 for more information