Trial Outcomes & Findings for Blocking Mifepristone Action With Progesterone (NCT NCT03774745)
NCT ID: NCT03774745
Last Updated: 2020-01-22
Results Overview
Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
at 14-16 days after mifepristone administration
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Progesterone
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
Follow-Up 1
|
5
|
6
|
|
Overall Study
Follow-up 2
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blocking Mifepristone Action With Progesterone
Baseline characteristics by cohort
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
n=99 Participants
|
24.1 years
n=107 Participants
|
27.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Gestational Age
|
49.5 days
n=99 Participants
|
55 days
n=107 Participants
|
52.5 days
n=206 Participants
|
|
BMI
|
24.8 kg/m^2
n=99 Participants
|
24.6 kg/m^2
n=107 Participants
|
24.6 kg/m^2
n=206 Participants
|
|
Obesity
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Gravidity
|
4.5 number of pregnancies
n=99 Participants
|
3.5 number of pregnancies
n=107 Participants
|
4 number of pregnancies
n=206 Participants
|
|
Parity
|
1.5 number of deliveries
n=99 Participants
|
0.5 number of deliveries
n=107 Participants
|
1 number of deliveries
n=206 Participants
|
|
Past mifepristone use
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Prior progesterone use (n, %)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 14-16 days after mifepristone administrationPopulation: Intention to treat
Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
Outcome measures
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Continuing Pregnancy Based on Ultrasound Examination
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 16 days after mifepristone administrationPopulation: intention to treat
Pregnancy expulsion following mifepristone treatment
Outcome measures
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Expulsion During Follow-up Evaluation
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 16 days after mifepristone administrationPopulation: increased to severe at any time during follow-up
Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
Outcome measures
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Nausea
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Vomiting
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Mastalgia
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Tiredness
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Mood changes
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Reflux
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Dizziness
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Bleeding
|
1 participants
|
3 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Spotting
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events During Follow-up Evaluation
Cramping
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 16 days after mifepristone administrationPopulation: intent to treat
Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures
Outcome measures
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Medical Safety During Treatment and Follow-up
Emergent D&C
|
0 participants
|
2 participants
|
|
Medical Safety During Treatment and Follow-up
Hemorrhage
|
1 participants
|
2 participants
|
|
Medical Safety During Treatment and Follow-up
Emergency Room Visit
|
1 participants
|
2 participants
|
|
Medical Safety During Treatment and Follow-up
Transfusion
|
0 participants
|
1 participants
|
|
Medical Safety During Treatment and Follow-up
Side effects - request D&C
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 16 days after mifepristone administrationPopulation: intent to treat
Change in serum progesterone and hCG during follow-up evaluation
Outcome measures
| Measure |
Progesterone
n=6 Participants
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 Participants
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
Progesterone increase from baseline at FU 1
|
5 participants
|
2 participants
|
|
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
Progesterone decrease from baseline at FU 1
|
0 participants
|
2 participants
|
|
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
hCG increase from baseline at FU 1
|
4 participants
|
3 participants
|
|
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
hCG decrease from baseline at FU 1
|
1 participants
|
3 participants
|
Adverse Events
Progesterone
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Progesterone
n=6 participants at risk
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 participants at risk
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage
|
16.7%
1/6 • Number of events 1 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
33.3%
2/6 • Number of events 2 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
|
Pregnancy, puerperium and perinatal conditions
Transfusion
|
0.00%
0/6 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
16.7%
1/6 • Number of events 1 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
|
Pregnancy, puerperium and perinatal conditions
Emergency D&C
|
0.00%
0/6 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
33.3%
2/6 • Number of events 2 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
|
Pregnancy, puerperium and perinatal conditions
Emergency Room Visit
|
16.7%
1/6 • Number of events 1 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
33.3%
2/6 • Number of events 2 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
Other adverse events
| Measure |
Progesterone
n=6 participants at risk
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.
|
Placebo Oral Capsule
n=6 participants at risk
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Side effects requesting study discontinuation
|
16.7%
1/6 • Number of events 1 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
16.7%
1/6 • Number of events 1 • Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D\&C
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place