Who may participate

This study is seeking healthy female participants.

Women of non-childbearing potential:
You may participate in this study provided that:

  • You are 18 or older, and
  • You have been surgically sterilised (hysterectomy or bilateral tubal ligation).

Women of childbearing potential:
At each visit to the PCRU, we will check that you are using the appropriate contraception.
You must fulfil one of the following conditions:

  • You have a non-hormonal IUD
  • You use a diaphragm
  • You use condoms
  • Your partner has undergone a vasectomy at least six months ago
  • You are abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

These non-hormonal contraceptive methods will have to be started at least 14 days before the start of the study and will have to be continued until Day 150 of the study.

In addition to the criteria listed, participants must meet the following requirements:

  • Weight of 45 kg minimum
  • Body Mass Index of 17.5 - 50 kg/m2
  • Non-smoker, ex-smoker, smoker
  • Able to meet all study visit requirements There are other requirements for participation in this study. The study staff will explain these to you during the screening process.
     

STUDY CALENDAR BUTTON

Condition

Healthy

Age

18 or older

Sex

Female

Long-term follow-up

a follow-up visit at the end of the study

How long is the study?

Approximately 7 months

Compensation

Up to € 2.285, plus travel fees

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

The study is planned to last for approximately 7 months.
Several examinations or procedures will be required in connection with the study:
• A screening examination, during which you will sign the study ICD;
• 1 treatment visit on Day 1 and 21 ambulatory visits on Day 2, 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 127 and 141.
• The follow up visit will take place on Day 150.