RecruitingPhase 4NCT05730205

Effects of the Contraceptive Implant in Women With Sickle Cell Disease


Sponsor

University of Pennsylvania

Enrollment

22 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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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Interventions

DRUGNexplanon 68 MG Drug Implant

Progestin contraceptive device


Locations(1)

Penn Medicine University City

Philadelphia, Pennsylvania, United States

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NCT05730205


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