Why is contraception or breast screening often a prerequisite when participating in a drug trial?

Regularly, FemTrials seeks women who want to participate in a medical scientific study or in a (clinical) drug trial to help develop new drugs for women, to help optimise the dosage or to help develop new medical diagnostics and treatments; so that other women can be helped. Usually, this research involves women aged 18 to 70+ years.

The use of contraception or having a breast examination (mammogram) is a condition in many clinical trials about which questions are regularly asked by women who want to participate in a drug trial or scientific study in which FemTrials participates as a Clinical Research Organisation (CRO).

Why do these conditions exist? And what exactly do we mean by them? Below are the most frequently asked questions about the contraceptive and breast screening conditions in various clinical drug trials and medical research studies in which FemTrials is involved as a CRO.

Why is contraception often a condition?

This has to do with the fact that a woman should not become pregnant during the study, or for a certain period afterwards. At this stage of the clinical trial, we do not yet know exactly how the drug might affect pregnancy. No adverse effects are expected, but safety comes first. The exact conditions regarding contraception may vary from study to study. In some drug trials, for example, women may not be fertile. In those studies where fertile women are allowed to participate, double contraception is often required. This means that if you have a partner of the opposite sex, both of you must use contraception. The woman (hormonal) contraception and the man a condom.

What about a future pregnancy?

After participating in the practical part of a research or study and after the follow-up examination, double contraception should be used for several weeks or months to be on the safe side. Until the study drug is no longer in the body. After this period, it is completely safe for a woman to become pregnant.

What types of contraception are recommended?

There are, of course, different forms of contraception available. For instance, there are contraceptive methods with or without hormones. It is important to know that hormonal contraception is not permitted for all scientific and drug trials. In the studies where hormonal contraception is allowed, a fertile woman could participate with:

• Birth control pill
• Implanon NXT contraceptive rod
• IUD (copper IUD or Flexi-T IUD)
• Kyleena IUD
• Mirena IUD
• Contraceptive ring
• Contraceptive patch
• Sterilization.

However, the above contraceptives should be used in combination with a (female) condom, diaphragm or cervical cap.

What other conditions can you participate with?

You can also take part in a study if you have been sterilised, have passed the menopause or if this applies to your partner. Being non-sexually active is also allowed in some cases. When this is part of your lifestyle, for example from your religious beliefs. Finally, non-heterosexual contact is also allowed when participating in a clinical drug trial.

Why is a breast examination sometimes requested?

A breast examination (usually based on a 3D mammography) aims to exclude that a woman who wants to participate in a drug trial has breast cancer. If this is the case and breast cancer is diagnosed, there is usually a hormonal imbalance and higher inflammation that can have a negative impact on the drug trial. Advantage for participating women, is that breast cancer can (sometimes) be detected by us at an earlier stage and treatment can be started earlier. However, if breast cancer is diagnosed, then participation in most drug trials is not possible.

Interested in participating in a scientific study or drug trial?

We are currently recruiting women who would like to participate in studies for, among others:

• Hormonal drug trial for women with sexual disfunction (FSIAD)
• Drug trial for Alzheimer
• Drug trial cardiovascular diseases
• Drug trial Parkinson’s disease
• Drug trial menopausal women
• Drug trial hormonal contraception
• Cervical cancer diagnostics
• Breast Implant Illness diagnostics.
• Pre Menstrual Dysphoric Disorder (PMDD) treatment.
• Persistent Genital Arousal Disorder (PGAD) diagnostics and treatment.

Are you interested in possibly participating in a study or clinical trial? If so, please contact us.