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Study
Information Sheet
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About Birth Control Pills:
Most birth control pills contain both estrogen and progesterone-like hormones. These hormones prevent pregnancy by reducing ovulation (releasing an egg) and making the cervical mucus too thick for sperm to enter the uterus. The hormones also regulate when you get your period. The traditional pill package contains 21 active drug (hormone) pills followed by 7 pills with no active drug (“sugar” or spacer pills), or a week of no pills. During those 7 days your body withdraws from the birth control hormones and period bleeding happens. Because the lining of the uterus becomes thin while using birth control pills, it may not be necessary to have the withdrawal bleeding or the period every month while using birth control pills.
Using Medicine to Reduce or Eliminate Periods is Not a New Idea:
Ever since there have been birth control pills some doctors have given some women pills every day so they have either no periods or reduced periods. Usually this was done for the rare patient with painful periods or when bleeding could harm a woman’s health. A common type of birth control today, Depo-Provera, is a shot of progesterone given every 3 months for birth control. In most women, it takes away the period after one year of use. The new hormone intrauterine device, Mirena, also reduces period bleeding by 90% after one year of use.
Do Women Need to Have Periods on the Pill?
Periods are important when a woman is trying to get pregnant. During a period the uterus sheds the blood lining, made by the natural cycle of hormones, to prepare to make a new blood lining so you can get pregnant. When you use birth control pills this uterine lining is thin and you are not trying to get ready for pregnancy. The uterine lining is not expected to “build up” or get thicker and thicker if you do not have a period while using the pill. For most women, seeing their monthly period blood tells them they are not pregnant. When you are on birth control pills you should not need a period to reassure you, because if you never miss a birth control pill, your chance of getting pregnant is expected to be small. Birth control pills have been around since the 1960’s and the type of pills we are using have not been shown to cause birth defects. Any pregnancy would be found early because during the study you will have a pregnancy test either at the clinic or at home every month. The study also performs testing of the lining of the uterus in some subjects at the beginning and end of the study to identify any problems.
Purpose of the “Continuous Pill” Study:
If you are in the study you will take a low dose birth control pill that is not yet approved by the US Food and Drug Administration and can only be used as part of a research study. The pill we are studying is a combination of levonogestrel (a progestin) and ethinyl estradiol (an estrogen). Levonorgestrel and ethinyl estradiol are female hormones commonly used in marketed birth control pills. However, taking the study dose every day is considered investigational. The study pills are very similar to Alesse®, a brand of pill sold in the US that has the same dose of estrogen as the study pills but a slightly higher dose of levonorgestrel. Birth control pills like Alesse® are FDA-approved for contraception and have low failure rates if used correctly, even with 7 days off the hormone pills every month for a period. During the study, you will take the study pill every day for an entire year. We will closely follow your bleeding patterns and ask you questions about any side effects you experience in order to further evaluate the safety of a continuous pill regimen. We will study period symtoms, like cramps or PMS, in some women both before and during the first 3 months of the study drug. These subjects will receive extra daily questionnaires to fill out for several months. We also want to learn more about the lining of the uterus when women skip their periods, so some women will have an endometrial biopsy (sample of their uterus lining) at the start and the end of the study. Because all estrogen containing birth control pills may increase your risk of blood clots, we are also going to perform additional blood tests in some women at the beginning, middle, and end of the study to see if there is any change without a period week. You will have 6-7 study visits including 3 pelvic exams, 3 pap tests, 2 mammograms (for women 40 and over), and 3-5 blood draws over the one year study. If you complete all study visits you will be paid $400 to $500 dollars and have free birth control pills and study visits.
How Do I Find Out More About the Study?
Call 206-520-4218 or 206-520-5060 and ask for more information about the “Continuous Pill” Study. We will ask you some questions to see if you might be a possible study candidate, and answer any of your questions.