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Clinical Trial Summary

The objective of this study is to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD.


Clinical Trial Description

Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, affecting 100,000 primarily Black people. The disease is characterized by chronic pain and infection, and ultimately reduces life expectancy by 20 years compared to people without SCD. Given the importance of effective contraception for women with sickle cell disease, as well as previously demonstrated therapeutic benefits of hormonal contraception, the etonogestrel implant may be an optimal method of contraception for women with SCD. This study aims to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD. This is a crossover study. Participants will be observed over two phases: 1) a 3-month phase with no hormonal contraceptive intervention and 2) a 6-month phase with the progestin implant. During the phase with no hormonal contraceptive intervention, participants must be willing to be abstinent or use a barrier method, or they must have had a permanent contraception procedure such as a tubal ligation or salpingectomy or be using the copper intrauterine device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05730205
Study type Interventional
Source University of Pennsylvania
Contact Arden McAllister, MPH
Phone 267-785-8044
Email arden.mcallister@pennmedicine.upenn.edu
Status Recruiting
Phase Phase 4
Start date June 8, 2023
Completion date February 15, 2025

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