Leiden University Medical Center
rgomperts
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.
Female Contraception
Mifepristone 50 mg
PHASE3
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 |
Estimated Enrollment : | 1186 participants |
Masking : | NONE |
Primary Purpose : | PREVENTION |
Official Title : | Prospective Phase III Multi-center Open-label Study of the Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive |
Actual Study Start Date : | 2024-09 |
Estimated Primary Completion Date : | 2028-09 |
Estimated Study Completion Date : | 2029-09 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 35 Years |
Sexes Eligible for Study: | FEMALE |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hospital Group Twente
Almelo, Netherlands, 7609 PP
Not yet recruiting
Amsterdam University Medical Centers
Amsterdam, Netherlands, 1105 AZ
Not yet recruiting
Medical Spectrum Twente
Enschede, Netherlands, 7512 KZ
Not yet recruiting
Martini Hospital
Groningen, Netherlands, 9728 NZ
Not yet recruiting
Leiden University Medical Center
Leiden, Netherlands, 2333 FOR
Not yet recruiting
Deaconess House
Utrecht, Netherlands, 3582 KE