Blocking Mifepristone Action With Progesterone

Pregnancy, Unwanted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03774745
• Other study ID #: 1353650
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 11, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: January 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 15, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, Unwanted

Intervention

Drug:
• Mifepristone 200 MG
All subjects receive mifepristone tablet on treatment day 1.
• micronized Progesterone
Subjects randomized to progesterone receive treatment starting day 2.
• Placebo oral capsule
Subjects randomized to placebo receive treatment starting day 2.

Locations

Country	Name	City	State
United States	Family Planning Associates	Sacramento	California
United States	Planned Parenthood Mar Monte	Sacramento	California
United States	University of California, Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuing Pregnancy Based on Ultrasound Examination	Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination	at 14-16 days after mifepristone administration
Secondary	Expulsion During Follow-up Evaluation	Pregnancy expulsion following mifepristone treatment	up to 16 days after mifepristone administration
Secondary	Number of Participants With Adverse Events During Follow-up Evaluation	Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed	up to 16 days after mifepristone administration
Secondary	Medical Safety During Treatment and Follow-up	Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures	up to 16 days after mifepristone administration
Secondary	Number of Participants With Change in Serum Progesterone and hCG During Follow-up	Change in serum progesterone and hCG during follow-up evaluation	up to 16 days after mifepristone administration