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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
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 13, 2018
Results First Submitted Date  ICMJE December 30, 2019
Results First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE February 11, 2019
Actual Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Continuing pregnancy [ Time Frame: at 14-16 days after mifepristone administration ]
pregnancy still in uterus with normal growth and gestational cardiac activity present
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
  • Expulsion During Follow-up Evaluation [ Time Frame: up to 16 days after mifepristone administration ]
    Pregnancy expulsion following mifepristone treatment
  • Number of Participants With 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
  • 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
  • Number of Participants With Change in Serum Progesterone and hCG During Follow-up [ Time Frame: up to 16 days after mifepristone administration ]
    Change in serum progesterone and hCG during follow-up evaluation
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Expulsion [ Time Frame: up to 16 days after mifepristone administration ]
    Pregnancy expulsion following mifepristone treatment
  • Pathology [ Time Frame: up to 16 days after mifepristone administration ]
    Pathologic changes in products of conception and differences between progesterone and placebo arms in women who have an aspiration procedure during or at the end of treatment
  • Adverse events [ Time Frame: up to 16 days after mifepristone administration ]
    Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
  • Medical safety [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blocking Mifepristone Action With Progesterone
Official Title  ICMJE A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Pregnancy, Unwanted
Intervention  ICMJE
  • 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
  • Drug: Placebo oral capsule
    Subjects randomized to placebo receive treatment starting day 2.
    Other Name: Placebo (for micronized progesterone)
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Mifepristone 200 MG
    • Drug: micronized Progesterone
  • 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.
    Interventions:
    • Drug: Mifepristone 200 MG
    • Drug: Placebo oral capsule
Publications * Creinin MD, Hou MY, Dalton L, Steward R, Chen MJ. Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):158-165. doi: 10.1097/AOG.0000000000003620.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
40
Actual Study Completion Date  ICMJE August 15, 2019
Actual Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Biologic females who are pregnant
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774745
Other Study ID Numbers  ICMJE 1353650
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Sharing de-identified data will be considered upon individual request
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Mitchell D Creinin, MD University of California, Davis
PRS Account University of California, Davis
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP