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NCT02513043 Clinical Trial

Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

Pregnancy Clinical Trial

Official title:
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02513043
Other study ID # 1031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2016
Est. completion date May 11, 2021

Study information
Verified date July 2020
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Description:

The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Recruitment information / eligibility
Status Completed
Enrollment 1470
Est. completion date May 11, 2021
Est. primary completion date May 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 50 Years
Eligibility Inclusion Criteria: - desires abortion Exclusion Criteria: - medically ineligible for procedure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• medical abortion
medical abortion

Locations
Country Name City State
United States Carafem Atlanta Georgia
United States Maine Family Planning Augusta Maine
United States Planned Parenthood of Montana Billings Montana
United States Carafem Chevy Chase Maryland
United States Planned Parenthood of the Rocky Mountains Denver Colorado
United States The University of Hawaii Women's Options Centers Honolulu Hawaii
United States Emma Goldman Clinic Iowa City Iowa
United States Choices Women's Medical Center Jamaica New York
United States Planned Parenthood of the Rocky Mountains New Mexico New Mexico
United States Maine Family Planning New York New York
United States Oregon Health and Sciences University Women's Health Research Unit Portland Oregon
United States Planned Parenthood Columbia Willamette Portland Oregon
United States Planned Parenthood Minnesota, North Dakota, South Dakota Saint Paul Minnesota
United States Carafem Skokie Illinois
United States Carafem Washington District of Columbia
United States Oregon Health and Sciences University Women's Health Research Unit Washington Washington
United States Planned Parenthood Columbia Willamette Washington Washington

Sponsors (1)
Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events as a measure of safety and tolerability adverse events 1 year
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