Study Information Sheet
Madigan No Period Study
The Effects on Bone Density with the Continuous Use of the Oral Contraceptive for Menstrual Cycle Suppression
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 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.
Do Women Need to Have a Period When Using Birth Control Pills?
Periods are important when a woman is trying to get pregnant. During a natural menstrual cycle the uterus builds a thick blood lining to prepare for an embryo to implant and make a pregnancy. If pregnancy does not happen, then this blood lining is lost a period and the cycle begins again. But when you use birth control pills you are not trying to get ready for a pregnancy and this blood lining is thin. For most women, seeing their period blood may tell them they are not pregnant, but when you are on birth control pill you should not need a period to reassure you, because the risk of getting pregnant is very low if you take the hormones every day. 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 do a pregnancy test every 3 months at home.
Bone Density and Hormonal Contraceptives
The hormonal contraceptive Depo-ProveraTM can also stop your period, but because it has no estrogen, these shots often reduce your bone density, which can increase your risk for bone fracture. The pills that we will be using in this study contain both a progestin and an estrogen, and this should protect your bones, but we do not know this for sure and that is the reason for the study. We can measure bone density with a test called a DEXA scan , which takes about 15 minutes, uses 1/10 the dose of radiation of a chest x-ray, and is painless. We know the regular use of many birth controls pill can protect your bone density and this study is to find out if skipping the period week will keep this benefit.
The Madigan No Period Study:
The birth control pills we are studying are a combination of levonorgestrel or norethindrone acetate (progestins) and ethinyl estradiol (an estrogen). The pills used in the study are FDA-approved for contraception and if you join the study, you will be randomly assigned to one of 2pill brands (like Alesse or LoEstrin 1/20 – or their generic versions) to use for the 1 ½ years. During the study, you will take a study pill every day for the 1 ½ years without a period week. We would like to find out which pill recipe will turn off your period bleeding the fastest, and which keeps it away for the 1 ½ years with every-day use. We will check your blood iron level, check you for anemia, and measure your bone density when you begin the study pills, and after 1 ½ years of use to see if there is any change in these tests. Because irregular bleeding is common in the first 6 months of continuous pill use, you will get a handout on continuous pill use and we want to help you so please call or email the study before stopping you pills. We will ask you to fill out a short questionnaire with each pill package (every 21 days) to tell us if you took your pills and how much bleeding you had. Even if you stop the study pills, we still want to follow you for the 1 ½ years to compare your bone density and bleeding to the other women who are skipping their periods on the pill.
How Do I Find Out More About the Study?
Call 253-968-XXXX, or ask your provider, for more information about the “No Period” study. We will ask you some questions to see if you might be a possible study candidate, and answer any of your questions.