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Blocking Mifepristone Action With Progesterone

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ClinicalTrials.gov Identifier: NCT03774745
Recruitment Status : Terminated (Safety)
First Posted : December 13, 2018
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pregnancy, Unwanted
Interventions Drug: Mifepristone 200 MG
Drug: micronized Progesterone
Drug: Placebo oral capsule
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 6 6
Follow-Up 1 [1] 5 6
Follow-up 2 [2] 4 2
Completed [3] 4 2
Not Completed 2 4
[1]
3 +/- 1 day after enrollment
[2]
7 +/1 day after enrollment
[3]
15 +/- 1 day after enrollment
Arm/Group Title Progesterone Placebo Oral Capsule Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
Intended to enroll 40 total - study stopped after 12 enrolled due to safety concerns
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
29.8
(24.6 to 39.6)
24.1
(20.9 to 33.8)
27.3
(20.9 to 39.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
2
  16.7%
Not Hispanic or Latino
5
  83.3%
5
  83.3%
10
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  33.3%
2
  33.3%
4
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  66.7%
1
  16.7%
5
  41.7%
White
0
   0.0%
3
  50.0%
3
  25.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6
 100.0%
6
 100.0%
12
 100.0%
Gestational Age  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 6 participants 6 participants 12 participants
49.5
(47 to 56)
55
(48 to 61)
52.5
(47 to 61)
BMI  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 12 participants
24.8
(19.0 to 36.4)
24.6
(22.7 to 52.3)
24.6
(19.0 to 52.3)
Obesity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
2
  33.3%
2
  33.3%
4
  33.3%
Gravidity  
Median (Full Range)
Unit of measure:  Number of pregnancies
Number Analyzed 6 participants 6 participants 12 participants
4.5
(1 to 10)
3.5
(1 to 12)
4
(1 to 12)
Parity  
Median (Full Range)
Unit of measure:  Number of deliveries
Number Analyzed 6 participants 6 participants 12 participants
1.5
(0 to 6)
0.5
(0 to 3)
1
(0 to 6)
Past mifepristone use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
1
  16.7%
3
  50.0%
4
  33.3%
Prior progesterone use (n, %)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Continuing Pregnancy Based on Ultrasound Examination
Hide Description Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
Time Frame at 14-16 days after mifepristone administration
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
2
  33.3%
2.Secondary Outcome
Title Expulsion During Follow-up Evaluation
Hide Description Pregnancy expulsion following mifepristone treatment
Time Frame up to 16 days after mifepristone administration
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2
  33.3%
3.Secondary Outcome
Title Number of Participants With Adverse Events During Follow-up Evaluation
Hide Description Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
Time Frame up to 16 days after mifepristone administration
Hide Outcome Measure Data
Hide Analysis Population Description
increased to severe at any time during follow-up
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Nausea 2 1
Vomiting 2 0
Mastalgia 0 0
Tiredness 0 1
Mood changes 1 0
Reflux 0 0
Dizziness 0 0
Bleeding 1 3
Spotting 0 0
Cramping 0 0
4.Secondary Outcome
Title Medical Safety During Treatment and Follow-up
Hide Description Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures
Time Frame up to 16 days after mifepristone administration
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Hemorrhage 1 2
Emergency Room Visit 1 2
Transfusion 0 1
Emergent D&C 0 2
Side effects - request D&C 1 1
5.Secondary Outcome
Title Number of Participants With Change in Serum Progesterone and hCG During Follow-up
Hide Description Change in serum progesterone and hCG during follow-up evaluation
Time Frame up to 16 days after mifepristone administration
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Progesterone increase from baseline at FU 1 5 2
Progesterone decrease from baseline at FU 1 0 2
hCG increase from baseline at FU 1 4 3
hCG decrease from baseline at FU 1 1 3
Time Frame Two weeks
Adverse Event Reporting Description Adverse event included hemorrhage, emergency room visit, transfusion, emergent D&C
 
Arm/Group Title Progesterone Placebo Oral Capsule
Hide Arm/Group Description

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 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.

All-Cause Mortality
Progesterone Placebo Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Progesterone Placebo Oral Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      2/6 (33.33%)    
Pregnancy, puerperium and perinatal conditions     
Hemorrhage   1/6 (16.67%)  1 2/6 (33.33%)  2
Transfusion   0/6 (0.00%)  0 1/6 (16.67%)  1
Emergency D&C   0/6 (0.00%)  0 2/6 (33.33%)  2
Emergency Room Visit   1/6 (16.67%)  1 2/6 (33.33%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Progesterone Placebo Oral Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      1/6 (16.67%)    
Pregnancy, puerperium and perinatal conditions     
Side effects requesting study discontinuation  [1]  1/6 (16.67%)  1 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
Requested D&C for abortion because could not tolerate medications/pregnancy
Early termination for safety reasons leading to small numbers of subjects analyzed for efficacy outcomes. Imbalance in participant characteristics due to early termination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mitchell Creinin
Organization: University of California, Davis
Phone: 916-734-6670
EMail: mdcreinin@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03774745    
Other Study ID Numbers: 1353650
First Submitted: December 11, 2018
First Posted: December 13, 2018
Results First Submitted: December 30, 2019
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020