The Phase 3 study of LPI 001 and LPI 002
- Conditions
- Medical Abortion
- Registration Number
- JPRN-jRCT2080224923
- Lead Sponsor
- inepharma International Limited (Ferring Pharmaceuticals Co., Ltd as ICCC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 120
Normal intrauterine pregnancy at 63 days or below on the visit of LPI 001 administration has been confirmed
-Subjects who are assessed as possible to have abortion in terms of clinical evaluation point of view which includes laboratory results, medical history.
-Willingness to undergo surgical termination of pregnancy if needed
-Suspected or diagnosed ectopic pregnancy or undiagnosed adnexal mass
-Intrauterine Device (IUD) in place (Note: the woman should be eligible once the IUD is removed)
-Chronic kidney disease
-Adrenal insufficiency
-Steroid-dependent asthma or other steroid dependent condition
-Subjects on long-term treatment with corticosteroids
-Known allergies to mifepristone, misoprostol, or any other prostaglandin
-Coagulopathies or ongoing treatment with anticoagulants
-Hereditary porphyria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The primary efficacy endpoint is abortion success rate from the LPI 001 administration up to 24 hours after the LPI 002 administration.<br>The primary efficacy endpoint will be summarised together with a 95% confidence interval (CI) using an Exact method.
- Secondary Outcome Measures
Name Time Method efficacy<br>Daily description of trial status (abortion, ongoing pregnancies, withdrawal for surgery upon request, or other reasons) in subjects with ongoing pregnancy from 24 hours after LPI 002 administration up to 14 days after LPI 001 administration.<br>Abortion success rate from LPI 002 administration up to 24 hours after LPI 002 administration will be summarised with a 95% confidence interval (CI) using an Exact method.