Ulipristal Acetate Oral Contraceptive Study
Clinical Trial Seeking Participants
eIRB study # 10023 (PI: Jeffrey Jensen, MD, MPH)
The Women’s Health Research Unit is conducting a study to learn more about a new estrogren-free contraceptive pill containing ulipristal acetate.
- Open to Enrollment
Why is this study being done?
There is a pressing need for estrogen-free oral contraception for women who cannot take estrogen-containing medications because of other health problems. This study is being done to learn about a pill that is being developed as a possible new method of birth control. The study drug is made of ulipristal acetate (UPA), an estrogen-free hormonal contraceptive that contains a selective progesterone-receptor modulator (SPRM). A SPRM is a hormone that may block the action of the hormone progesterone. The oral pill releases the hormone into your body. The hormone is intended to keep women from releasing an egg so they do not get pregnant. Other birth control pills work the same way. It is not known how well the new contraceptive pill will work in preventing a woman from becoming pregnant. This study is intended to help find out what effects this SPRM estrogen-free hormone will have on women who use the pill.
The purpose of this study is to determine:
- If there are any effects of the study pill on menstrual periods, ovulation (releasing an egg from the ovary), preventing pregnancies and bleeding;
- How safe the study pill is to use every day;
- How much SPRM, estrogen-free hormone needs to be in the study pill to make sure that it prevents pregnancy;
- How the study drug in the study pill affects your rate of ovulation (how often you release an egg);
- How the SPRM, estrogen-free hormone used in the study pill are absorbed by the body;
- Whether the study drug in the study pill affects your everyday life and if it causes any side effects different from what we know about side effects from other contraceptives; if the side-effects from this study pill are more or less serious than the side-effects from other hormonal contraceptives.
Who is eligible to participate?Women who are:
- 18 – 35 years of age
- Are in good general health
- Have regular menstrual cycles (between 21 and 35 days)
- Are willing to use a barrier method of birth control (if sexually active with a male partner) or have had a tubal ligation, or have a partner who has had a vasectomy.
- Are willing to travel to OHSU for 39-47 visits over 6.5 months of study participation
What is the compensation for this study?
Qualifying participants in the approximately 6.5 month study will receive:
- Confidential medical exams.
- Study medication.
- Compensation of up to $2,680 for time and travel (over the duration of the study).