NCT03774745

Blocking Mifepristone Action With Progesterone

A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy, Unwanted

Interventions

Type	Name	Description
DRUG	Mifepristone 200 MG	All subjects receive mifepristone tablet on treatment day 1.
DRUG	micronized Progesterone	Subjects randomized to progesterone receive treatment starting day 2.
DRUG	Placebo oral capsule	Subjects randomized to placebo receive treatment starting day 2.

Timeline

• Start date: 2019-02-11
• Primary completion: 2019-07-29
• Completion: 2019-08-15
• First posted: 2018-12-13
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study