Die Studie

Clinical trial of a new compound that is under development for the treatment of menopausal symptoms.

  • You are a healthy male or female
  • You are between 16 and 65 years old
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial.

As a female you can only participate if you are not pregnant and not breast feeding and meet one of the following conditions:

  • You are using a copper intra-uterine device;
  • You have passed the menopause (no menses for at least 12 months);
  • You have been sterilized or your male partner has been sterilized.

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom;
  • You have been sterilized or your female partner is sterilized or postmenopausal;
  • You abstain from sexual intercourse (you are not sexually active) according to your lifestyle.

Note: 

  • For this trial, you cannot (have) receive(d) a Covid-19 vaccine within 14 days (for vaccines with 2 injections) or 27 days (for vaccines with 1 injection) prior to the start of the trial. For vaccines with 2 injections, you are not allowed to participate if you are between the first and second injection.
  • You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the screening of this clinical trial (counting from the last administration),
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

Zeitraum

  • The trial consists of 1 period during which you will stay in the research facility in Groningen for 21 days (20 nights).
  • The follow-up visit will take place within 14 days after your departure from the research facility.
Group 1  
stay 27 Oct 2021 up to and including 16 Nov 2021
note Follow up on appointment between November 17 and 30, 2021
Group 2  
stay 3 Nov 2021 up to and including 23 Nov 2021
note Follow up on appointment between November 24 and December 7, 2021

Aufwandsentschädigung

  • You will receive a gross compensation of € 3343 for participation in one of the groups.

Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.