A Phase 4 interventional study of Mifepristone and Misoprostol in Abortion Failure, sponsored by Gynuity Health Projects. Terminated at 14 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.
This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies \<= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours.
The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later.
Drug: Mifepristone · Drug: Misoprostol · Drug: Placebo misoprostol
Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose.
Drug: Misoprostol · Drug: Placebo mifepristone
200mg oral mifepristone
Also known as: Mifeprex
800mcg buccal misoprostol
Also known as: Cytotec
Matching placebo pill of 200mg mifepristone
Matching placebo pills of 800mcg misoprostol
The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.
Time frame: One week after taking first study medication
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
Time frame: One week after taking first study medication
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
Time frame: One week after taking first study medication
Plan to share: No
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This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects