Blocking Mifepristone Action With Progesterone

• Status: Terminated
• Trial end date: 2019-08-15
• Target enrollment: 0
• Participant gender: Female

Summary

Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Collaborators: Athenium; Society of Family Planning
• Treatments: Mifepristone; Progesterone

Criteria

Inclusion Criteria:

1. Pregnant females 18 years and older at enrollment.

2. Seeking surgical abortion at 44-63 days' gestation on Study day 1.

3. Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.

4. Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.

5. English-speaking

6. Willing to sign informed consent and follow study protocol.

7. Willing to experience potential expulsion of the pregnancy with mifepristone treatment.

Exclusion Criteria:

1. Medical contraindications to medical abortion.

1. Poorly controlled hypertension (systolic BP >160 or diastolic BP >95)

2. Significant anemia - known recent hemoglobin <9.5 gm/dL

3. Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)

4. Breastfeeding

5. Coagulopathy or therapeutic coagulation

6. Ultrasound evidence of molar or ectopic pregnancy

7. Chronic systemic corticosteroid use

8. Adrenal disease

9. Sickle cell anemia with frequent/recent crises

10. Glaucoma

2. IUD in place during conception, even if removed.

3. Peanut allergy.

4. Known intolerance of mifepristone or progesterone.

5. Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.