Effects of the Contraceptive Implant in Women With Sickle Cell Disease (SCD CURE)

University of Pennsylvania

Status and phase: Enrolling; Phase 4

Conditions: Sickle Cell Disease

Treatments: Drug: Nexplanon 68 MG Drug Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05730205

855708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female aged 18-45
• Diagnosis of sickle cell disease (SS or SB0)
• 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

• SC Disease
• Use of Depo Provera in the past 6 months
• Changes to sickle cell medications in the past 3 months
• Contraindications to use of Nexplanon device as per clinical standards
• Currently pregnant or pregnant within the last month or seeking to become pregnant
• Currently breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Nexplanon

Active Comparator group

Treatment:

Drug: Nexplanon 68 MG Drug Implant

Baseline

No Intervention group