NCT05730205

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Nexplanon 68 MG Drug Implant	Progestin contraceptive device

Timeline

• Start date: 2023-06-08
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2023-02-15
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study