Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC

Women who will be considered for this study are those who are presently taking combination estrogen/progestin contraception for at least 2 months. They must be between the ages of 18 and 48 years with a body mass index of 40 or less. Study participants will be asked to keep a daily diary of symptoms based on the symptoms listed above. This requires ranking the severity of bleeding, pelvic pain, mood, and headaches based on a scale defined on the daily diary. All subjects will keep track of any pain medication that they take on a medication log.

Subjects that are not sure if their symptoms (mood, pelvic pain or headache) increase on days 1-3 and 18-28, will be asked to keep the diary while taking their current contraceptive medication. After they record their symptoms in the diary, it will be evaluated by the study coordinator to see if they qualify (which means that mood, pelvic pain and headache must have increased on days 1-3 and 18-28 compared to days 4-17). If they qualify, visit 1 will be scheduled.

At visit 1, subjects will undergo a physical exam and a pelvic exam. Subjects may be required to have a Pap smear if one has not been performed or if there is not sufficient documentation of one within the past year. Subjects will be given a single pack of Loestrin 1/20 for cycle #1 along with their symptoms calendars and medication log.

All women will begin the study with one month of Loestrin 1/20, to be taken in a normal 21/7 manner, and will complete a daily questionnaire. To continue in the study, subjects must be classified as having substantial fluctuation in their symptoms. At visit 2, (end of cycle #1), subjects will return their completed calendar to the study coordinator. The calendar will be reviewed for compliance and for eligibility based on symptom criteria. Subjects will also be scheduled for lab work. Women who continue in the study will be randomly assigned either to a group to start taking Loestrin 24 Fe (24 real pills and 4 placebo pills - Group 1), or to a group to continue taking Loestrin 1/20 in the standard 21/7 fashion for an additional 3 cycles (Group 2). All women will be asked to continue keeping a daily log of their symptoms, which will be turned in to the study coordinator at each of the scheduled visits.

Subjects will not be given the choice initially as to which group they will be placed; however all women will be given the opportunity to evaluate the 24/4 regimen. After the first 3 randomized cycles (visit 3), subjects will turn in their calendars to the study coordinator. Group 1 will be given a choice between continuing Loestrin 24 Fe or going back to Loestrin 1/20. Group 1 will complete a brief survey regarding their choice and will be given 3 packs of the pill of choice. All Group 2 subjects will be switched onto 3 cycles of Loestrin 24 Fe. Subjects in both groups will continue keeping their daily symptoms calendar.