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Safety
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Experimental | 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. |
|
| Placebo oral capsule | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone 200 MG | Drug | All subjects receive mifepristone tablet on treatment day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion During Follow-up Evaluation | Pregnancy expulsion following mifepristone treatment | up to 16 days after mifepristone administration |
| Number of Participants With Adverse Events During Follow-up Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
Medical contraindications to medical abortion.
IUD in place during conception, even if removed.
Peanut allergy.
Known intolerance of mifepristone or progesterone.
Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
Biologic females who are pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell D Creinin, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Mar Monte | Sacramento | California | 95816 | United States | ||
| University of California, Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31809439 | Derived | 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. |
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Sharing de-identified data will be considered upon individual request
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2. |
| FG001 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intended to enroll 40 total - study stopped after 12 enrolled due to safety concerns
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuing Pregnancy Based on Ultrasound Examination | Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination | Intention to treat | Posted | Count of Participants | Participants | at 14-16 days after mifepristone administration |
|
Two weeks
Adverse event included hemorrhage, emergency room visit, transfusion, emergent D&C
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effects requesting study discontinuation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Requested D&C for abortion because could not tolerate medications/pregnancy |
Early termination for safety reasons leading to small numbers of subjects analyzed for efficacy outcomes. Imbalance in participant characteristics due to early termination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitchell Creinin | University of California, Davis | 916-734-6670 | mdcreinin@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2019 | Jan 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomized, double blind, placebo controlled trial
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placebo pills in opaque bottle
| micronized Progesterone | Drug | Subjects randomized to progesterone receive treatment starting day 2. |
|
|
| Placebo oral capsule | Drug | Subjects randomized to placebo receive treatment starting day 2. |
|
|
Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
| 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 | up to 16 days after mifepristone administration |
| 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 |
| Sacramento |
| California |
| 95817 |
| United States |
| Family Planning Associates | Sacramento | California | 95825 | United States |
| BG001 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gestational Age | Median | Full Range | days |
|
| BMI | Median | Full Range | kg/m^2 |
|
| Obesity | Count of Participants | Participants |
|
| Gravidity | Median | Full Range | number of pregnancies |
|
| Parity | Median | Full Range | number of deliveries |
|
| Past mifepristone use | Count of Participants | Participants |
|
| Prior progesterone use (n, %) | Count of Participants | Participants |
|
| 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2. |
|
|
| Secondary | Expulsion During Follow-up Evaluation | Pregnancy expulsion following mifepristone treatment | intention to treat | Posted | Count of Participants | Participants | 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 | increased to severe at any time during follow-up | Posted | Number | participants | 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 | intent to treat | Posted | Number | participants | 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 | intent to treat | Posted | Number | participants | up to 16 days after mifepristone administration |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 1 |
| 6 |
| EG001 | 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. Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1. Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2. | 0 | 6 | 2 | 6 | 1 | 6 |
| Transfusion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Emergency D&C | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Emergency Room Visit | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
|
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| D011083 |
| Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| Mastalgia |
|
| Tiredness |
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| Mood changes |
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| Reflux |
|
| Dizziness |
|
| Bleeding |
|
| Spotting |
|
| Cramping |
|
| Transfusion |
|
| Emergent D&C |
|
| Side effects - request D&C |
|
| hCG increase from baseline at FU 1 |
|
| hCG decrease from baseline at FU 1 |
|