Emergency Contraception and BMI

eIRB #16291, PI: Alison Edelman, MD, MPH

The Women's Health Research Unit is conducting a study to examine a higher dose of the emergency contraceptive pill containing levonorgestrel and its ability to prevent ovulation in women of higher BMI. This study will also compare how well emergency contraceptive pill containing ulipristal acetate works in women of varying BMIs.

Why is this study being done?

Currently, women have two different types of emergency contraceptive pills available to use, one containing levonorgestrel (LNG, otherwise known as Plan B©) and another containing ulipristal acetate (UPA, otherwise known as Ella©). Women of higher weight and BMI are more likely than women of lower weight and BMI to experience a failure of the emergency contraceptive containing LNG. It is unclear if this is also an issue for the emergency contraceptive containing UPA. We are testing a different amount of the emergency contraceptive containing LNG to determine if we can improve its effectiveness for women of higher BMI and weight. In addition, we are performing studies to confirm how well the emergency contraceptive containing UPA works for women of higher BMI and weights as well as testing a different dose amount. The overall goal of this research is to improve the effectiveness of emergency contraception for women, no matter their weight or BMI. 

The purpose of this study is:
  • To determine if a different dose of LNG-containing emergency contraception in women of higher BMI and weight prevents the ovary from releasing an egg (ovulation) better than the normal dose of LNG-containing emergency contraception.
  • To compare drug levels and ovarian activity between women of higher and lower BMIs with UPA-containing emergency contraception and to test a different dose of UPA-containing emergency contraception in women of higher BMI.


Eligibility:

Women who are between the ages of 18-35 who:
  • Have normal menstrual cycles
  • Have both a BMI of 30 mg/k2 or higher and a weight of 176 lbs or more.
  • Are willing to use non-hormonal contraception during the study such as a condom or other barrier method
  • Are not currently using a hormonal form of birth control

Even if you have a Copper-IUD or have had a Tubal Ligation, you may still qualify for this study.

Compensation

There are two parts of this study. Qualified participants may be able to participate in both parts of the study and may be compensated up to $2,140 for time and travel. Study participation for both parts would last approximately 5 months and would include approximately 39 visits. Study visits are timed with the start of a woman's menstrual cycle and are concentrated during a 2 week time period in the beginning to middle of each menstrual cycle with gaps of time in between where no study visits would occur. Study visits may occur on weekends or holidays depending on participant's menstrual cycle. 

If a participant only participates in the LNG-containing Emergency Contraceptive portion of the study, participation would last approximately 2 months and would include approximately visits. Participants will be compensated up to $620 for time and travel. 

If a participant only participates in the UPA-containing Emergency Contraceptive portion of the study, participation would last approximately 4 months and the number of visits would be approximately 25 visits. Participants may be compensated up to $1,520 for time and travel.

Who do I contact for additional information?

To find out more information and to learn if you are qualified to participate, fill out the online form or call the Women’s Health Research Unit confidential recruitment line.

Complete the Online Form or call 503-494-3666, or email