Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive. With this, we want to confirm that the chances of getting pregnant while using this contraceptive are very small. We also want to demonstrate that the use of mifepristone is safe, and it does not lead to any severe health problems. We expect fewer side effects compared to other frequently used contraceptives with hormones. Mifepristone does not contain these hormones. It is important to know how people experience that use of one tablet a week.
Mifepristone 50 mg, a progesterone receptor modulator, is a proven safe emergency contraceptive and a promising new weekly contraceptive. As mifepristone does not contain estrogens or progestogens, we anticipate users will not experience the undesirable side effects and health risks of current hormonal contraceptives. Furthermore, pills are a highly desired formulation approach and a weekly regimen instead of daily administration will likely contribute to a high acceptability and adherence among users. Based on promising early stage clinical data, we expect the use of weekly mifepristone 50 mg as a contraceptive will be safe, effective, and acceptable.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,186
Once-weekly oral mifepristone 50 mg
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
RECRUITINGZiekenhuisgroep Twente
Almelo, Netherlands
NOT_YET_RECRUITINGFlevoziekenhuis
Almere Stad, Netherlands
NOT_YET_RECRUITINGAmsterdam Universitair Medische Centra
Amsterdam, Netherlands
NOT_YET_RECRUITINGMedisch Spectrum Twente
Enschede, Netherlands
RECRUITINGAdmiraal De Ruyter Ziekenhuis
Goes, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Netherlands
RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Netherlands
RECRUITINGLeiden University Medical Center
Leiden, Netherlands
RECRUITINGMaastricht Universitair Medisch Centrum
Maastricht, Netherlands
NOT_YET_RECRUITING...and 4 more locations
Overall Pearl Index
Nominator Number of pregnancies with conception during treatment period from the first day of pill intake to the last day of pill intake + 7 days Denominator The time period from the first day of pill intake to the last day of pill intake + 7 days. Cycles with documentation of no unprotected intercourse will be subtracted from this period, unless in the unlikely case that a pregnancy occurred in such a cycle.
Time frame: 0-12 months
Pearl Index by Method failure
Nominator Number of pregnancies with conception during cycles as defined in the denominator Denominator The number of cycles with perfect use times 1300. A cycle is defined as (at least) 28 days after the first day of mifepristone 50 mg intake. Cycles with documentation of no unprotected intercourse will be subtracted from this time period, unless in the unlikely case that a pregnancy occurred in such a cycle. Also, cycles with non-perfect use, i.e. without mifepristone 50 mg intake at least once every 7 days will be excluded. Diary charts and counting of remaining tablets will provide dosing information to determine (non-) perfect use.
Time frame: 0-12 months
Assess the contraceptive safety of once-weekly mifepristone 50 mg
Proportion of women with endometrial thickness \>15 mm, endometrium with irregular cystic appearance on US; with ALT, AST elevation three times above normal levels or bilirubin two times above normal levels; with adverse events / serious adverse events
Time frame: 3, 6 and 12 months
Depression
PHQ-9 questionnaire (mean value) and changes
Time frame: baseline, 3, 6 and 12 months
Sexual functioning
Female Sexual Function Index (FSFI) (mean value) and changes
Time frame: baseline, 3, 6 and 12 months
Use of antidepressants
Proportion of participants who use antidepressants or mood stabilizing drugs
Time frame: baseline, 3, 6 and 12 months
Weight [kg]
Weight changes
Time frame: baseline, 3, 6 and 12 months
Bleeding profile
Daily reported bleeding pattern and changes in bleeding pattern regarding amount of bleeding, pain, use of painkillers and effect on hemoglobin
Time frame: 0-365 days
Side effects
Proportion of participants with daily reported side-effects and changes
Time frame: 0-365 days
Acceptability
Proportion of participants who find the medication acceptable
Time frame: 3, 6 and 12 months
Liver function
Frequency of abnormal liver functions between 2 and 3 x ULN (ALT/AST) and time to become less than 2 x ULN
Time frame: 3, 6 and 12 months
Pregnancy outcomes
Number of abortions, miscarriages, ectopic pregnancies, preterm labor, growth restriction and congenital abnormalities
Time frame: 21 months
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