RECRUITINGPhase 4INTERVENTIONAL
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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. waiting period after previous treatment 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Nexplanon 68 MG Drug Implant
Progestin contraceptive device
Locations (1)
Penn Medicine University City
Philadelphia, Pennsylvania, United States