Simply answered: Yes, but all measures are taken to only test effective medications
Modern medicine wants to make birth control/contraception better, more effective, and with fewer side effects. Many investigational research studies, including multiple in Utah, are currently underway studying investigational oral contraceptives (OBC) and other birth control methods like intra-vaginal rings (IVR). Investigational means not yet approved by the United States Food and Drug Administration (but the research study is approved to be conducted). Some people may hesitate to participate because of misperceptions about risks of participating in clinical trials of this nature.
Some misconceptions some people may have include:
- There is a chance I could become pregnant
- This new drug might affect my reproductive system in the future
If it’s a study about OBC, I could get pregnant if the new medication doesn’t work, right? Yes that is correct, but actually the medications being studied have already undergone many rounds of testing before the human trials begin. Furthermore, the drug compounds being studied in many of these trials are often already used in other approved contraceptives; the study drug may contain less hormone. The compound often isn’t entirely new, meaning researchers already know a lot about safety and efficacy.
Researchers are confident at the point of human testing that the OBC or other being studied prevents pregnancy similar to approved marketed medications. Studies are needed to calculate a more exact rate of efficacy, and to fully understand side effects that may occur. As a general rule, contraceptive clinical trials do not involve a placebo (placebos are non-active). Investigational contraception drugs may be tested against other forms of approved birth control or are studied in “Open-Label” studies (no comparator).
Research is very comprehensive when it comes to new medications. In early phases, safety of the OBC/other compound studied is carefully examined. In early stage research human participants will often take the experimental medication while using barrier methods of contraception (condoms/spermicide). In later tests such as Phase III trials, participants will forego the backup methods.
Participants in studies should understand the risks. Remember, there is chance you could become pregnant with FDA-approved and marketed contraceptive. The reason for researching new birth control methods is to identify compounds with effective and safe results …better than what is currently available!
Why People Participate in Clinical Trials for Birth Control Methods
- No cost Investigational medication birth control
- Potential to receive study visit compensation
- Helping science advance for others future benefit can be rewarding