| Age: | 18 - 40 years old |
| Gender: |
Female
|
| Healthy Volunteers: | Yes |
| Keywords: | Birth control shot, Women's health, Long acting, Birth control |
| Type: | Phase 1, Drug study |
| Target: |
128 Participants
|
We are looking for women already using non-hormonal birth control methods (condoms, copper IUD, tubes tied or a partner who had his tubes tied) or who are not sexually active with a man. We are NOT looking for women who want to use this study shot as their birth control method.
Women who participate will get a single study birth control shot and will be followed until ovulation returns. We want to understand how long the new shot works (which we think will be about 6 months), and its effect on the menstrual cycles. This study will also help us learn about possible side-effects.
The hormone used in the shot, called levonorgestrel, is already used in other approved birth control methods like some birth control pills, emergency contraception, and hormonal IUDs. The study shot has currently not been approved by the FDA, which is why we are doing this study.
There will be no cost to you for study medication, study doctor’s time or procedures related to this study. Compensation for your time is provided.
Participation involves a significant time commitment, so please consider whether it will fit into your daily schedule.
For most women, we expect that you will have about 36 visits over 9 months. The study period includes:
- about 1 to 1-½ months of screening
- up to 6 months of visits after you get the shot
- 1 to 1-½ months to check when your period comes back after the shot wears off
We expect your total time in the study to last up to 9 months. But, if the shot ends up not working for a full 6 months, it is possible that your time in the study may be shorter. This study requires that you have a lot of flexibility in coming in for visits on different days and different times of days. This will include typical business hours and may be evening, weekend, or holiday visits during the 9 months you are participating in the study.
On the day you get the shot, you will need to stay for multiple blood tests. You will have four visits in the first week, then two visits the second week, then one visit per week until it looks like you are getting close to releasing an egg. At each visit you may have a pelvic exam, a vaginal ultrasound exam, and a blood draw.
- Women between the ages of 18 and 40
- Not looking to use this investigational shot as birth control method at this time
- Using non-hormonal birth control methods (condoms, copper IUD, tubes tied or a partner who had his tubes tied) or not sexually active with a man
- Have an intact uterus and at least one ovary
- Have normal menstrual cycles when not using hormones
- Are in good general health
- Have a BMI of less than 40
| Location |
Suite 2500
Sacramento, CA 95817
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.