Blocking Mifepristone Action With Progesterone

Phase 2TerminatedNCT03774745

University of California, Davis12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pregnancy, Unwanted

Interventions

Mifepristone 200 MGDRUG

All subjects receive mifepristone tablet on treatment day 1.

micronized ProgesteroneDRUG

Subjects randomized to progesterone receive treatment starting day 2.

Placebo oral capsuleDRUG

Subjects randomized to placebo receive treatment starting day 2.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Planned Parenthood Mar Monte

Sacramento, California, United States

University of California, Davis

Sacramento, California, United States

Family Planning Associates

Sacramento, California, United States

Outcomes

Primary Outcomes

Continuing Pregnancy Based on Ultrasound Examination

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

Secondary Outcomes

Expulsion During Follow-up Evaluation

Pregnancy expulsion following mifepristone treatment

Time frame: up to 16 days after mifepristone administration

Number of Participants With Adverse Events During Follow-up Evaluation

Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed

Time frame: up to 16 days after mifepristone administration

Medical Safety During Treatment and Follow-up

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

Number of Participants With Change in Serum Progesterone and hCG During Follow-up

Change in serum progesterone and hCG during follow-up evaluation

Time frame: up to 16 days after mifepristone administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.