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NCT01902485 Clinical Trial

Study of Immediate Start of Progestin Contraceptives in Medical Abortion

Contraception Clinical Trial

— Quickstart  

Official title:
Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01902485
Other study ID # 1009
Secondary ID
Status Completed
Phase Phase 4
First received July 15, 2013
Last updated March 3, 2016
Start date July 2013
Est. completion date December 2015

Study information
Verified date March 2016
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.

Recruitment information / eligibility
Status Completed
Enrollment 937
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

Women having medical abortion desiring progestin-based contraceptives (injectables or implants)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Timing of Contraceptive Initiation in Medical Abortion

Locations
Country Name City State
Mexico Centro de Salud Beatriz Velasco de Aleman Mexico City
Mexico Centro de Salud Santa Catarina Mexico City
United States Bayview Medical Center Baltimore Maryland
United States Boston Medical Center Boston Massachusetts
United States Planned Parenthood League of Massachusetts Boston Massachusetts
United States Planned Parenthood of the Pacific Southwest Chula Vista California
United States Planned Parenthood Northern California Eureka California
United States Planned Parenthood of Southern New England Stamford Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Medical Abortion Failure One month after enrollment No
Primary Repeat Pregnancy 6 months after enrollment No
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