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Trial record 2 of 3 for:    grossman, mifeprex

Medication Abortion Via Pharmacy Dispensing

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ClinicalTrials.gov Identifier: NCT03320057
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and the Hawaiian Islands
Information provided by (Responsible Party):
Daniel Grossman, University of California, San Francisco

Brief Summary:
This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.

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

Detailed Description:
Improving access to and efficiency of abortion provision is important for patients and providers. The Risk Evaluation and Mitigation Strategy (REMS) requires that Mifeprex ® ( mifepristone) be dispensed only from a doctor's office, clinic or hospital (not from a pharmacy by prescription) by a certified health care provider and the health care provider must obtained a signed Patient Agreement Form before dispensing mifepristone. Data are needed to investigate the feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. In order to address the study question, a mixed methods study design is appropriate. To assess feasibility, the study will collect data on pharmacists' satisfaction with dispensing mifepristone. To assess acceptability, qualitative data will be collected from pharmacists about their perspectives on dispensing Mifeprex before and after the study, as well as measure patient satisfaction through open-ended and close-ended survey questions. To assess effectiveness of the pharmacy dispensing model, the study will evaluate clinical outcomes from electronic health records. The proposed feasibility study would take place at sites in California and Washington states.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Alternative Provision of Medication Abortion Via Pharmacy Dispensing
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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 receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit




Primary Outcome Measures :
  1. Number of pharmacists who refuse to dispense Mifeprex [ Time Frame: End of the study, month 24 ]
    Number of pharmacists who refuse to dispense Mifeprex at least once during the study period.

  2. Number of pharmacists who report being satisfied with pharmacy dispensing of Mifeprex [ Time Frame: End of the study, month 24 ]
    Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?"


Secondary Outcome Measures :
  1. Number of participants who report being satisfied with obtaining Mifeprex in the pharmacy [ Time Frame: Day 2 following initial medication abortion visit ]
    Number of participants who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?"

  2. Number of participants with a complete abortion with medication alone and who do not require a surgical procedure to complete the abortion [ Time Frame: Up to 6 weeks after initial visit ]
    Number of participants who report that their "abortion is now complete and they are no longer pregnant" and who did not "end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion"

  3. Number of participants with an adverse event [ Time Frame: Up to 6 weeks after initial visit ]
    Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill

  4. Change in proportion of knowledge questions related to medication abortion answered correctly by pharmacists [ Time Frame: Before and after the intervention, approximately month 1 and month 24 of the study to assess change in knowledge ]
    Change in proportion of knowledge questions related to medication abortion answered correctly by pharmacists (out of 12 possible knowledge questions, with 0 questions correct meaning lowest knowledge and 12 questions correct meaning highest knowledge)



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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females seeking medication abortion
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • Women seeking medication abortion through 70 days gestation
  • Eligible for Mifeprex® at a study clinical site
  • English or Spanish speaking
  • Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone

Patient Exclusion Criteria:

  • Not pregnant
  • Not seeking medication abortion
  • Under the age of 15
  • Contraindications for medication abortion

    • All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.

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): NCT03320057


Contacts
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Contact: Shelly Kaller, MPH 510-986-8945 shelly.kaller@ucsf.edu
Contact: Sarah Raifman, MPH 510-986-8974 sarah.raifman@ucsf.edu

Locations
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United States, California
Obstetrics and Gynecology Family Planning Clinic at University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Mitchell Creinin, M.D.    916-734-6670    mdcreinin@ucsdavis.edu   
Women's Health Services at University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Sarah Averbach, MD    619-543-7878    saverbach@ucsd.edu   
Kaiser Permanente Northern California Recruiting
San Francisco, California, United States, 94115
Contact: Tina Raine-Bennett, MD    510-891-5930    Tina.R.Raine-Bennett@kp.org   
Mt. Zion Women's Options Clinic, University Completed
San Francisco, California, United States, 94115
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Elizabeth Micks, MD    206-598-5500    emicks@uw.edu   
Planned Parenthood of the Great Northwest and the Hawaiian Islands Recruiting
Tacoma, Washington, United States, 98405
Contact: Erin Berry, MD, MPH    800-769-0045    erin.berry@ppgnhi.org   
Sponsors and Collaborators
University of California, San Francisco
University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and the Hawaiian Islands
  Study Documents (Full-Text)

Documents provided by Daniel Grossman, University of California, San Francisco:
Study Protocol  [PDF] August 1, 2019


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Responsible Party: Daniel Grossman, Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03320057     History of Changes
Other Study ID Numbers: A128753
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: August 9, 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
Keywords provided by Daniel Grossman, University of California, San Francisco:
medication abortion
mifepristone
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