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Search / Trial NCT05730205

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

Launched by UNIVERSITY OF PENNSYLVANIA · Feb 6, 2023

Trial Information

Current as of August 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a contraceptive implant, called Nexplanon, on women with sickle cell disease (SCD). The aim is to see how well this implant is accepted by patients and whether it helps reduce the painful episodes known as vaso-occlusive crises, improves quality of life, and affects blood health in women who experience frequent pain episodes. The trial is currently recruiting female participants aged 18 to 45 who have been diagnosed with SCD and have had at least one painful episode each month over the last six months. Participants will need to stop any hormonal birth control for a month before joining the study.

If you decide to participate, you'll have regular check-ins and be asked to share your experiences with the implant. It's important to note that this study is only for women who are not currently pregnant, breastfeeding, or planning to become pregnant soon. If you meet the eligibility criteria and are interested, this trial could provide valuable information about managing your condition while using a contraceptive method.

Gender

FEMALE

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

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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