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Blocking Mifepristone Action With Progesterone

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ClinicalTrials.gov Identifier: NCT03774745
Recruitment Status : Terminated (Safety)
First Posted : December 13, 2018
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Pregnancy, Unwanted Drug: Mifepristone 200 MG Drug: micronized Progesterone Drug: Placebo oral capsule Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: placebo pills in opaque bottle
Primary Purpose: Treatment
Official Title: A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: Mifepristone 200 MG
All subjects receive mifepristone tablet on treatment day 1.
Other Name: Mifeprex

Drug: micronized Progesterone
Subjects randomized to progesterone receive treatment starting day 2.
Other Name: Prometrium

Placebo Comparator: 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.
Drug: Mifepristone 200 MG
All subjects receive mifepristone tablet on treatment day 1.
Other Name: Mifeprex

Drug: Placebo oral capsule
Subjects randomized to placebo receive treatment starting day 2.
Other Name: Placebo (for micronized progesterone)




Primary Outcome Measures :
  1. Continuing pregnancy based on ultrasound examination [ Time Frame: 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 :
  1. Expulsion during follow-up evaluation [ Time Frame: up to 16 days after mifepristone administration ]
    Pregnancy expulsion following mifepristone treatment

  2. Adverse events during follow-up evaluation [ Time Frame: up to 16 days after mifepristone administration ]
    Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed

  3. Medical safety during treatment and follow-up [ Time Frame: up to 16 days after mifepristone administration ]
    Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures

  4. Change in serum progesterone and hCG during follow-up evaluation [ Time Frame: up to 16 days after mifepristone administration ]
    Change in serum progesterone and hCG during follow-up evaluation

  5. Pathology evaluation (exploratory) [ Time Frame: up to 16 days after mifepristone administration ]
    Pathologic changes in products of conception and differences between progesterone and placebo arms in a subset of women who have an aspiration procedure during or at the end of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologic females who are pregnant
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774745


Locations
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United States, California
Planned Parenthood Mar Monte
Sacramento, California, United States, 95816
University of California, Davis
Sacramento, California, United States, 95817
Family Planning Associates
Sacramento, California, United States, 95825
Sponsors and Collaborators
University of California, Davis
Society of Family Planning
Investigators
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Principal Investigator: Mitchell D Creinin, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03774745     History of Changes
Other Study ID Numbers: 1353650
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing de-identified data will be considered upon individual request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
mifepristone
progesterone
abortion
Additional relevant MeSH terms:
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Mifepristone
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents