Contraception requirements for participation in clinical trials
4 questions about contraception requirements regarding participation in clinical trials answered
Contraception is a requirement that often raises questions. Why does this requirement exist and what does it entail?
Below you will find the answers to the 4 most frequently asked questions about contraception requirements regarding participation in a clinical trial.
1. Why is contraception a requirement?
This requirement is in place because during the clinical trial, or for a certain period thereafter, it is not permissible for a woman to become pregnant. In this phase of the clinical research, the exact effect of the drug on pregnancy is not yet known. Although no adverse effects are expected, safety is paramount.
The specific contraceptive requirements may vary depending on the trial. For example, some clinical trials may not allow participation of fertile women. In trials where fertile women can participate, dual contraception is required. This means that both the woman (hormonal contraception) and the man (condom) must use contraception if they have a partner of the opposite sex.
2. What are the consequences for a future pregnancy?
After the period of stay and follow-up evaluation of a clinical triap, dual contraception needs to be continued for a few weeks or months until the investigational substance is no longer present in the body.
After this period, it is completely safe for a woman to conceive.
3. What types of contraception are available?
There are various forms of contraception available, both hormonal and non-hormonal. It's important to note that not all clinical trials permit the use of hormonal contraception. In trials where hormonal contraception is allowed, fertile women can participate using:
- The pill
- Contraceptive implant
- Hormonal or copper intrauterine device (IUD)
- Contraceptive ring
- Contraceptive patch
However, it's necessary to use these methods in combination with a (female) condom, diaphragm, or cervical cap.
4. What other requirements are there for participation?
In addition to the mentioned contraception requirements, you can also participate in a trial if you have been sterilized, have reached menopause, or if this applies to your partner.
In some cases, being sexually inactive is also allowed, for example, if it is part of your lifestyle based on religious beliefs.
Finally, participation is also possible for non-heterosexual individuals.
