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Recruiting Phase 4 NCT05730205

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

Trial Parameters

Condition Sickle Cell Disease
Sponsor University of Pennsylvania
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 22
Sex FEMALE
Min Age 18 Years
Max Age 45 Years
Start Date 2023-06-08
Completion 2026-06-15
Interventions
Nexplanon 68 MG Drug Implant

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.

Eligibility Criteria

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

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