The Phase 3 study of LPI 001 and LPI 002

A MULTICENTRE, OPEN-LABEL PHASE III TRIAL INVESTIGATING THE EFFICACY AND SAFETY OF LPI 001 AND LPI 002 FOR ARTIFICIAL TERMINATION OF PREGNANCY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224923

Enrollment

120

Registered

2019-10-17

Start date

2019-10-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Abortion

Interventions

investigational material(s) Generic name etc : mifepristone, misoprostol INN of investigational material : mifepristone, misoprostol Therapeutic category code : 249 Other hormone preparations (includi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
efficacy The primary efficacy endpoint is abortion success rate from the LPI 001 administration up to 24 hours after the LPI 002 administration. The primary efficacy endpoint will be summarised together with a 95% confidence interval (CI) using an Exact method.	—

Secondary

Measure	Time frame
efficacy 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. 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.	—

Measure

Time frame

efficacy 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. 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.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026