Sickle Cell Disease
Conditions
Brief 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.
Interventions
DRUGNexplanon 68 MG Drug Implant
Progestin contraceptive device
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female aged 18-45 * Diagnosis of sickle cell disease (SS, SB 0, SB+, SC) * Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months * Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study. * Access to a device with text messaging capability * Must be able to read and understand English * Willing to comply with study procedures
Exclusion criteria
* Use of Depo Provera in the past 6 months * Changes to sickle cell medications in the past 3 months * Regular blood transfusions * History of hematopoeitic stem cell transplantation * Contraindications to use of Nexplanon device as per clinical standards (not including history of venous thromboemblosim \[VTE\]) * Currently pregnant or pregnant within the last month or seeking to become pregnant * Currently breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of vaso-occlusive crises | 9 months | Self-reported pain crises, discrete pain episodes will be separated by at least 2 weeks |
Countries
United States
Outcome results
None listed