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Completed

NCT Number: NCT03913104

Mail Order Mifepristone Study

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 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. 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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Oakland, Oakland, California, United States

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About this study

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 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

Primary outcomes

  1. Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion

    Time frame: Day 14 following initial medication abortion visit

    Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.

  2. Acceptability: Would Use Mail-Order Dispensing Again

    Time frame: Day 14 following initial medication abortion visit

    Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.

Secondary outcomes

  1. Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3

    Time frame: Day 3 following initial medication abortion visit

    Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.

  2. Feasibility: Confidentiality Maintained When Receiving Medications by Mail

    Time frame: Day 3 following initial medication abortion visit

    Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.

  3. Clinical Effectiveness of Mail-Order Medication Abortion

    Time frame: Up to 6 weeks after initial medication abortion visit.

    Percentage of participants who experienced a complete medication abortion, by abortion instance.

  4. Clinical Safety of Mail-Order Medication Abortion

    Time frame: Up to 6 weeks after initial medication abortion visit.

    Percentage of participants who experience adverse events related to the abortion, by abortion instance.

  5. Provider Acceptability of Mail-Order Dispensing of Medication Abortion

    Time frame: Up to 3 months after data collection completed.

    Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.

Sponsors and collaborators

Lead sponsor

Daniel Grossman, MD

Other

Registry information

Official study title

Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2019
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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