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History of Changes for Study: NCT03774745
Blocking Mifepristone Action With Progesterone
Latest version (submitted August 23, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 11, 2018 Nothing (earliest Version on record)
2 December 17, 2018 Outcome Measures, Arms and Interventions, Study Description, Oversight, Sponsor/Collaborators and Study Status
3 February 19, 2019
Recruitment Status
, Study Status, Contacts/Locations and Outcome Measures
4 April 9, 2019 Study Status and Contacts/Locations
5 August 7, 2019
Recruitment Status
, Study Status, Study Design and Contacts/Locations
6 August 23, 2019
Recruitment Status
, Study Status, Contacts/Locations and Outcome Measures
Comparison Format:

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Changes (Side-by-Side) for Study: NCT03774745
December 11, 2018 (v1) -- August 7, 2019 (v5)

Changes in: Study Status, Outcome Measures, Study Design, Contacts/Locations, Arms and Interventions, Study Description, Oversight and Sponsor/Collaborators

Study Identification
Unique Protocol ID: 1353650 1353650
Brief Title: Blocking Mifepristone Action With Progesterone Blocking Mifepristone Action With Progesterone
Official Title: A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
Secondary IDs:
Study Status
Record Verification: December 2018 August 2019
Overall Status: Not yet recruiting Suspended
Study Start: February 2019 February 11, 2019
Primary Completion: January 2020 [Anticipated ] July 29, 2019 [Actual ]
Study Completion: February 2020 [Anticipated ] August 29, 2019 [Anticipated ]
First Submitted: December 11, 2018 December 11, 2018
First Submitted that
Met QC Criteria:
December 11, 2018 December 11, 2018
First Posted: December 13, 2018 [Actual ] December 13, 2018 [Actual ]
Last Update Submitted that
Met QC Criteria:
December 11, 2018 August 7, 2019
Last Update Posted: December 13, 2018 [Actual ] August 9, 2019 [Actual ]
Sponsor/Collaborators
Sponsor: University of California, Davis University of California, Davis
Responsible Party: Sponsor Sponsor
Collaborators: Society of Family Planning
Athenium
Society of Family Planning
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Data Monitoring: No No
Study Description
Brief Summary: We propose a double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone. 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. 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.

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
Conditions: Pregnancy, Unwanted Pregnancy, Unwanted
Keywords: mifepristone
progesterone
abortion
mifepristone
progesterone
abortion
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 1/Phase 2Phase 1/Phase 2
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: TripleParticipant, Care Provider, InvestigatorTripleParticipant, Care Provider, Investigator, Outcomes Assessor
Allocation: RandomizedRandomized
Enrollment: 40 [Anticipated ] 12 [Actual ]
Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Mifeprex
Drug: micronized Progesterone
Subjects randomized to progesterone receive treatment starting day 2.

Other Names:
  • 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 Names:
  • Mifeprex
Drug: Placebo oral capsule
Subjects randomized to placebo receive treatment starting day 2.

Other Names:
  • Placebo (for micronized progesterone)
Outcome Measures
Primary Outcome Measures:
1. Continuing pregnancy
pregnancy still in uterus with normal growth and gestational cardiac activity present

[Time Frame: at 14-16 days after mifepristone administration ]
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 Outcome Measures:
2. Expulsion
Pregnancy expulsion following mifepristone treatment

[Time Frame: up to 16 days after mifepristone administration ]
Expulsion during follow-up evaluation
Pregnancy expulsion following mifepristone treatment

[Time Frame: up to 16 days after mifepristone administration ]
3. Pathology
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

[Time Frame: up to 16 days after mifepristone administration ]
Pathology evaluation
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

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

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

[Time Frame: up to 16 days after mifepristone administration ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: Female Female
Gender Based: Yes Yes
Biologic females who are pregnant Biologic females who are pregnant
Accepts Healthy Volunteers: YesYes
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.

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.
Contacts/Locations
Central Contact: Mitchell D. Principal Investigator, MD
Telephone: 1-916-734-6846
Email: hs-obgynresearch@ucdavis.edu
Central Contact Backup: Courtney Study Coordinator
Telephone: 1-916-734-6846
Email: hs-obgynresearch@ucdavis.edu
Study Officials: Mitchell D Creinin, MD
Principal Investigator
University of California, Davis
Mitchell D Creinin, MD
Principal Investigator
University of California, Davis
Locations: United States, CaliforniaUnited States, California
Planned Parenthood Mar Monte
Sacramento, California, United States, 95816
Contact: Study coordinator (UC Davis)
Planned Parenthood Mar Monte
Sacramento, California, United States, 95816
University of California, Davis
Sacramento, California, United States, 95817
Contact: Study coordinator
Principal Investigator: Mitchell D. Creinin, MD
University of California, Davis
Sacramento, California, United States, 95817
IPDSharing
Plan to Share IPD: No
Sharing de-identified data will be considered upon individual request
No
Sharing de-identified data will be considered upon individual request
References
Citations:
Links:
Available IPD/Information:

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