Contraceptive Implant for Sickle Cell Disease
(SCD CURE Trial)
Trial Summary
What is the purpose of 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.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop any hormonal contraception and have a 1-month washout period before enrolling. Other medications for sickle cell disease should not have changed in the past 3 months.
Will I have to stop taking my current medications?
The trial requires you to stop any hormonal contraception and have a 1-month period without it before joining. However, it does not specify if you need to stop other medications.
What data supports the idea that Contraceptive Implant for Sickle Cell Disease is an effective treatment?
The available research does not provide specific data on the effectiveness of the contraceptive implant for treating Sickle Cell Disease. The studies focus on the use of etonogestrel in contraceptive methods like the NuvaRing and Implanon, mainly discussing their pharmacokinetics, safety, and effects on metabolic profiles. There is no direct evidence from these studies supporting its use for Sickle Cell Disease.12345
What safety data is available for the contraceptive implant used in sickle cell disease trials?
The contraceptive implant, known as Nexplanon or Implanon, contains etonogestrel and has been studied for its safety profile. While generally considered safe, there are reports of rare adverse events such as delayed-type hypersensitivity reactions. A study in France assessed the incidence of adverse effects associated with the etonogestrel implant, indicating that safety data is available and has been evaluated.12567
Is the contraceptive implant Nexplanon generally safe for humans?
Is the drug Nexplanon a promising treatment for Sickle Cell Disease?
How is the contraceptive implant Nexplanon different from other treatments for sickle cell disease?
Nexplanon is unique because it is a contraceptive implant that releases etonogestrel, a hormone, over three years, and is typically used for birth control, not for treating sickle cell disease. Its use in this context is novel, as it is not a standard treatment for sickle cell disease, which usually involves managing pain and preventing complications.238910
Eligibility Criteria
This trial is for women aged 18-45 with Sickle Cell Disease (specifically SS or SB0 types) who experience at least one pain episode a month. Participants must not be on hormonal contraception, pregnant, breastfeeding, or planning to become pregnant soon. They should have stable sickle cell medication use and no contraindications to the Nexplanon implant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
No Hormonal Intervention
Participants are observed for 3 months without hormonal contraceptive intervention, using either abstinence, barrier methods, or other non-hormonal contraceptive methods
Progestin Implant
Participants receive the progestin implant and are observed for its impact on vaso-occlusive crises, quality of life, and hematologic parameters
Follow-up
Participants are monitored for safety and effectiveness after the treatment phases
Treatment Details
Interventions
- Nexplanon
Nexplanon is already approved in United States, European Union, Canada, United Kingdom for the following indications:
- Birth control
- Birth control
- Birth control
- Birth control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor