early medication abortion
Conditions
Interventions
Three doses of LPI 001 are orally administered for one subject
50 mg (low dose) in Period 1, 100 mg (medium dose) in Period 2, and 200 mg (high dose) in Period 3. Each IMP should be administered orally as a single dose with 200 mL of water after at least a 10-hou
Sponsors
Shiozawa Toshiaki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Japanese or Caucasian women aged 20 years or older and younger than 65 years at the time of informed consent (2) A body mass index (BMI) of 18.5 or more and less than 30.0 at screening visit
Exclusion criteria
Exclusion criteria: (1) Subjects who are positive for the pregnancy test at the screening or on the day before administration of the IMP, or are breastfeeding (2) Subjects with a history of surgical procedures on the myometrium, such as hysterectomy, or a current Medical history of dysmenorrhea or menorrhagia (3) Subjects with a complication or a history of endometriosis, uterinefibroids, or hyperprolactinemia (4) Subjects with a complication or a history of malignant neoplasm (5) Subjects with a complication affecting blood coagulation or fibrinolytic system (6) Subjects with a history of hypersensitivity to IMP (7) Subjects who have received hormone therapy with estrogen or progesterone within the past 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phamacokinetics, Safety | — |
Contacts
Public ContactToshiaki Shiozawa
Mediscience Planing Inc.
Outcome results
None listed