Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Women on Waves | UNKNOWN |
| Children's Investment Fund Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone 50 mg | Experimental | mifepristone 50 mg once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone 50 mg | Drug | Once-weekly oral mifepristone 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | PHQ-9 questionnaire (mean value) and changes | baseline, 3, 6 and 12 months |
| Sexual functioning | Female Sexual Function Index (FSFI) (mean value) and changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gomperts, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Alkmaar | 1815 JD | Netherlands | |||
| Ziekenhuisgroep Twente |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline, 3, 6 and 12 months |
| Use of antidepressants | Proportion of participants who use antidepressants or mood stabilizing drugs | baseline, 3, 6 and 12 months |
| Weight [kg] | Weight changes | 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 | 0-365 days |
| Side effects | Proportion of participants with daily reported side-effects and changes | 0-365 days |
| Acceptability | Proportion of participants who find the medication acceptable | 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 | 3, 6 and 12 months |
| Pregnancy outcomes | Number of abortions, miscarriages, ectopic pregnancies, preterm labor, growth restriction and congenital abnormalities | 21 months |
| Almelo |
| 7609 PP |
| Netherlands |
| Flevoziekenhuis | Almere Stad | 1315 RA | Netherlands |
| Amsterdam Universitair Medische Centra | Amsterdam | 1105 AZ | Netherlands |
| Medisch Spectrum Twente | Enschede | 7512 KZ | Netherlands |
| Admiraal De Ruyter Ziekenhuis | Goes | 4462 RA | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 NZ | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Franciscus Gasthuis | Rotterdam | 3045 PM | Netherlands |
| Diakonessenhuis | Utrecht | 3582 KE | Netherlands |
| Maxima Medisch Centrum | Veldhoven | 5504 DB | Netherlands |
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided