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Mail Order Mifepristone Study

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ClinicalTrials.gov Identifier: NCT03913104
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Grossman, University of California, San Francisco

Brief Summary:
This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10-15 primary care and internal medicines sites not currently providing abortion services around the country. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.

Condition or disease Intervention/treatment Phase
Abortion Early Pregnancy Related Drug: Mifepristone Phase 4

Detailed Description:
This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 15-20 clinics and/or medical facilities not currently providing medication abortion to participate in the study. The study team will train primary care providers to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit approximately 400 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)
Drug: Mifepristone
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.




Primary Outcome Measures :
  1. Proportion of patients who report positive experience. [ Time Frame: Day 14 following initial medication abortion visit ]
    Proportion of patients reporting whether they would use the mail order service again if they needed another abortion.


Secondary Outcome Measures :
  1. Proportion of patients who report timely delivery of medication. [ Time Frame: Day 3 following initial medication abortion visit ]
    Proportion of patients who receive medications by Day 2 and Day 3 and proportion of patients who indicate their confidentiality was maintained when receiving medications by mail. The investigators will also estimate the proportion of patients who report that medications were lost, stolen or damaged.

  2. Proportion of patients who have a complete abortion [ Time Frame: Up to 6 weeks after initial medication abortion visit. ]
    Using electronic health record data related to abortion, the investigators will estimate the proportion of patients who experience a complete abortion and the proportion of patients who experience complications, including adverse or severe adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women seeking medication abortion through 63 days gestation
  • Eligible for MifeprexⓇ at a study site
  • English or Spanish speaking
  • Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit

Exclusion Criteria:

  • Not pregnant
  • Not seeking medication abortion
  • under the age of 15
  • Over 63 days gestation
  • Contraindicated for medication 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): NCT03913104


Contacts
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Contact: Rana Barar, MPH 510-986-8974 rana.barar@ucsf.edu
Contact: Sarah Raifman, MSc 510-986-8970 sarah.raifman@ucsf.edu

Locations
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United States, New York
Albert Einstein College of Medicine Not yet recruiting
New York, New York, United States, 10461
Contact: Marji Gold, MD         
Principal Investigator: Marji Gold, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Daniel Grossman, MD University of California, San Francisco

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Responsible Party: Daniel Grossman, Professor and Director of ANSIRH, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03913104     History of Changes
Other Study ID Numbers: 18-26819
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents