Abortion, Induced
Conditions
Keywords
medical abortion, mifepristone, misoprostol, buccal administration
Brief summary
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
Interventions
DRUG800 mcg misoprostol via oral or buccal administration
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* be willing and able to sign consent forms; * be eligible for medical abortion according to clinician's assessment; * be willing to undergo a surgical completion if necessary; * have ready and easy access to a telephone and emergency transportation; * speak English, Spanish, or have a translator available to translate for all study procedures; and, * agree to comply with the study procedures and visit schedule.
Exclusion criteria
* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; * IUD in place; * Chronic renal failure; * Concurrent long-term corticosteroid therapy; * History of allergy to mifepristone, misoprostol or other prostaglandin; * Hemorrhagic disorders or concurrent anticoagulant therapy; * Inherited porphyrias; or * Other serious physical or mental health conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| acceptability | — |
Countries
United States
Outcome results
None listed