Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
The comound being tested in this study is not a new drug; it is already available on the market. The drug comes in two formulations; both are approved for use. And you will receive both compositions during the study.
The drug is a protein identical to follicle stimulating hormone (FSH). FSH is a body's own hormone that stimulates the growth and maturation of the follicles in the ovaries. Ovaries are the vesicles in which eggs mature. When an egg is fully matured, the vesicle bursts open and the egg is released (ovulation). This causes a woman to be fertile. Women with low FSH levels may have problems getting pregnant. Treatment with the drug may be able to help women ovulate and become pregnant.
During this study, we will examine how quickly and to what extent the drug is absorbed, transported and excreted from the body. In addition, we will look at how the body processes the drug in a different composition. We will also study how safe the drug is and how well it is tolerated by healthy woman.
Pleas note:
WHO CAN PARTICIPATE IN THIS TRIAL?
Note
You can only participate if you are not pregnant, not breast feeding, and meet one of the following conditions:
THE COMPENSATION FOR THIS TRIAL
HOW LONG DOES THIS RESEARCH TAKE?
The trial starts with 1 short visit. After that, there will be two periods during which you will stay in the research facility in Groningen for 9 days (8 nights) per period. The follow-up visit will take place on the day of discharge from your last stay at the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
More about this clinical trial
The compound is a protein identical to follicle-stimulating hormone (FSH). FSH is a body’s own hormone that stimulates the growth and maturation of egg follicles in the ovaries. Follicles are the vesicles in which egg cells mature. When an egg is fully matured, the vesicle bursts open and the egg is released (ovulation). This makes a woman fertile. Women with low FSH levels may have problems getting pregnant. Treatment with the compound could help women to ovulate and become pregnant.
The compound tested in this study is not a new compound; it is already available on the market. The compound comes in two formulations. Both are authorized for use. You will receive both of these. In this trial we will investigate how quickly and to what extent the compound is absorbed, transported, and eliminated from the body. In addition, we look at how the body processes the compound in a different composition. We also investigate how safe the compound is and how well it is tolerated when it is used by healthy females.
You will be given the compound two times as an injection under the skin (subcutaneous). You will also be given an approved combined contraceptive pill (Marvelon) once daily as a tablet that you swallow, which means you will have to stop taking your own contraceptive pill during the trial. You will start taking this contraceptive pill 3 weeks before the first compound administration. During the trial, you will continue to use this contraceptive pill. After the follow-up visit, you can use your own contraceptive pill again. For this trial, you will receive a diary to keep track of your daily intake of the contraceptive pill at home or at the research facility.
After you have passed the medical screening, a gynecological examination and a cervical smear test will be done, and a transvaginal ultrasound (TVUS) will be made. This will be performed during a separate visit. A cervical smear is used to check for infections of the cervix. A smooth, tube-shaped tool (speculum) is inserted into your vagina which allows your doctor to see your cervix. A small brush will be used to take a sample of the cells in your cervix. You may experience discomfort and bleeding from where the sample is collected, but this should stop within a few hours. For the TVUS, a narrow rod-shaped instrument will be inserted into your vagina. A TVUS itself will likely take between 15 and 60 minutes and will be done by a gynecologist. A gynecological examination and a cervical smear will also be done at the follow-up visit, and a TVUS will take place three more times during the trial. These procedures may cause some discomfort, but should not cause any pain.
Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.
Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.
Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.
Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!
Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.