A Phase 2/3 interventional study of Levonorgestrel and Mifepristone in Pregnancy Early and Pregnancy Related, sponsored by Gynuity Health Projects. Not yet recruiting. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Gynuity Health Projects · Phase 2/3, Interventional, and Treatment
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.
The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)
Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.
Drug: Levonorgestrel · Drug: Mifepristone
Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.
Drug: Mifepristone
Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
Participants in both groups will receive one tablet of 200 mg mifepristone
Efficacy of the missed period pills regimen
Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment
Time frame: Two weeks
Effectiveness of the missed period pills regimen
Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
Time frame: Two weeks
Effectiveness at inducing return of menses within 10 days of missed menses
Proportion of participants who experience menstrual bleeding after taking the study medications
Time frame: One to two weeks
Safety/side effects
Incidence of side effects and complications
Time frame: Two weeks
Acceptability
Proportion of participants who report that the missed period pills service was acceptable or highly acceptable
Time frame: Two weeks
No study locations are listed for this record.
Start is estimated for Jul 2024; primary completion for Jun 2025, 11 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mifepristone