Blocking Mifepristone Action With Progesterone

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pregnancy, Unwanted

In brief

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

Key facts

Study ID

NCT03774745

Run by

University of California, Davis

People needed

12

Starts

2019-02-11

Expected to finish

2019-08-15

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant females 18 years and older at enrollment.
• Seeking surgical abortion at 44-63 days' gestation on Study day 1.
• Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
• Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
• English-speaking
• Willing to sign informed consent and follow study protocol.
• Willing to experience potential expulsion of the pregnancy with mifepristone treatment.

You may not qualify if…

• Medical contraindications to medical abortion.
• Poorly controlled hypertension (systolic BP >160 or diastolic BP >95)
• Significant anemia - known recent hemoglobin <9.5 gm/dL
• Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
• Breastfeeding
• Coagulopathy or therapeutic coagulation
• Ultrasound evidence of molar or ectopic pregnancy
• Chronic systemic corticosteroid use
• Adrenal disease
• Sickle cell anemia with frequent/recent crises
• Glaucoma
• IUD in place during conception, even if removed.
• Peanut allergy.
• Known intolerance of mifepristone or progesterone.
• Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.

Where it is running

• Planned Parenthood Mar Monte — Sacramento, California, United States
• University of California, Davis — Sacramento, California, United States
• Family Planning Associates — Sacramento, California, United States

Full record on ClinicalTrials.gov

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