Blocking Mifepristone Action With Progesterone

Phase 1

Terminated

Interventions: Drug: Mifepristone 200 MG
Drug: Placebo oral capsule
Drug: micronized Progesterone

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

Detailed Description: Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.

Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.

No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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
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.

Arm && Interventions

Group	Intervention	Description
Progesterone	Mifepristone 200 MG	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.
Placebo oral capsule	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.
Placebo oral capsule	Mifepristone 200 MG	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.
Progesterone	micronized 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.

Primary Outcome Measures

Name	Time	Method
Continuing Pregnancy Based on Ultrasound Examination	at 14-16 days after mifepristone administration	Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events During Follow-up Evaluation	up to 16 days after mifepristone administration	Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
Expulsion During Follow-up Evaluation	up to 16 days after mifepristone administration	Pregnancy expulsion following mifepristone treatment
Medical Safety During Treatment and Follow-up	up to 16 days after mifepristone administration	Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures
Number of Participants With Change in Serum Progesterone and hCG During Follow-up	up to 16 days after mifepristone administration	Change in serum progesterone and hCG during follow-up evaluation

Locations (3): Planned Parenthood Mar Monte
🇺🇸
Sacramento, California, United States
Family Planning Associates
🇺🇸
Sacramento, California, United States
University of California, Davis
🇺🇸
Sacramento, California, United States