Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cuidado Integral de la Mujer, Gineclinic, S.C. | UNKNOWN |
| Servicios de Salud Medieg, A. C | UNKNOWN |
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levonorgestrel plus mifepristone | Experimental | Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone. |
|
| Placebo plus mifepristone | Experimental | Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel | Drug | Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the missed period pills regimen | Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment | 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 | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness at inducing return of menses within 10 days of missed menses | Proportion of participants who experience menstrual bleeding after taking the study medications | One to two weeks |
| Safety/side effects |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Bousieguez | Contact | 212-448-1230 | mbousieguez@gynuity.org |
| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mifepristone | Drug | Participants in both groups will receive one tablet of 200 mg mifepristone |
|
Incidence of side effects and complications
| Two weeks |
| Acceptability | Proportion of participants who report that the missed period pills service was acceptable or highly acceptable | Two weeks |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |