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History of Changes for Study: NCT02513043
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Latest version (submitted April 2, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 30, 2015 Nothing (earliest Version on record)
2 August 4, 2015 Study Design and Study Status
3 March 8, 2016 Study Status
4 August 5, 2016
Recruitment Status
, Study Status, Contacts/Locations and Oversight
5 May 10, 2017 Study Status, Contacts/Locations and Study Design
6 October 27, 2017 Study Status and Contacts/Locations
7 May 22, 2018 Study Status and Contacts/Locations
8 May 31, 2018 Contacts/Locations and Study Status
9 April 2, 2019 Study Status, Contacts/Locations and Eligibility
Comparison Format:

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Study NCT02513043
on Date:  July 30, 2015 (v1)

Study Identification
Unique Protocol ID: 1031
Brief Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Official Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Secondary IDs:
Study Status
Record Verification: July 2015
Overall Status: Not yet recruiting
Study Start: September 2015
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: July 24, 2015
First Submitted that
Met QC Criteria:
July 30, 2015
First Posted: July 31, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 30, 2015
Last Update Posted: July 31, 2015 [Estimate]
Sponsor/Collaborators
Sponsor: Gynuity Health Projects
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Study Description
Brief Summary: This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.
Detailed Description: The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.
Conditions
Conditions: Pregnancy
Keywords:
Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 50 [Anticipated]
Number of Groups/Cohorts 0
Groups and Interventions
Intervention Details:
Drug: medical abortion
medical abortion
Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events as a measure of safety and tolerability
adverse events

[Time Frame: 1 year]
Eligibility
Study Population: Women seeking abortion
Sampling Method: Non-Probability Sample
Minimum Age: 11 Years
Maximum Age: 50 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure
Contacts/Locations
Locations:
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services