Effects of the Contraceptive Implant in Women With Sickle Cell Disease

• Status: Not yet recruiting
• Trial end date: 2024-02-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Etonogestrel

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