22 Participants Needed

Contraceptive Implant for Sickle Cell Disease

(SCD CURE Trial)

AM
Overseen ByArden McAllister, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 10 JurisdictionsThis treatment is already approved in other countries

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?

Nexplanon, a contraceptive implant containing etonogestrel, is generally considered safe, but it can rarely cause moderate or severe allergic reactions, which usually resolve after removal of the implant.12567

Is the drug Nexplanon a promising treatment for Sickle Cell Disease?

The articles mainly discuss Nexplanon as a contraceptive implant, highlighting its effectiveness in providing long-term birth control. They do not provide information on its use or promise as a treatment for Sickle Cell Disease.238910

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

Willing to comply with study procedures
I am a woman aged between 18 and 45.
I have been diagnosed with sickle cell disease.
See 4 more

Exclusion Criteria

I have sickle cell disease.
Contraindications to use of Nexplanon device as per clinical standards
Currently pregnant or pregnant within the last month or seeking to become pregnant
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

No Hormonal Intervention

Participants are observed for 3 months without hormonal contraceptive intervention, using either abstinence, barrier methods, or other non-hormonal contraceptive methods

3 months

Progestin Implant

Participants receive the progestin implant and are observed for its impact on vaso-occlusive crises, quality of life, and hematologic parameters

6 months

Follow-up

Participants are monitored for safety and effectiveness after the treatment phases

4 weeks

Treatment Details

Interventions

  • Nexplanon
Trial OverviewThe study tests the Nexplanon contraceptive implant's effects on women with Sickle Cell Disease. It aims to see if it changes the number of pain crises they have, affects their quality of life, or alters blood parameters related to their condition.
Participant Groups
2Treatment groups
Active Control
Group I: NexplanonActive Control1 Intervention
Group II: BaselineActive Control1 Intervention

Nexplanon is already approved in United States, European Union, Canada, United Kingdom for the following indications:

🇺🇸
Approved in United States as Nexplanon for:
  • Birth control
🇪🇺
Approved in European Union as Nexplanon for:
  • Birth control
🇨🇦
Approved in Canada as Nexplanon for:
  • Birth control
🇬🇧
Approved in United Kingdom as Nexplanon for:
  • Birth control

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Findings from Research

The study assessed the pharmacokinetics of etonogestrel and ethinylestradiol from the NuvaRing in 16 healthy women, finding that maximum serum levels were reached in about one week after insertion.
While the NuvaRing provided similar systemic exposure to etonogestrel compared to the oral contraceptive, it resulted in approximately 50% lower exposure to ethinylestradiol, suggesting a potentially different safety and efficacy profile for the vaginal ring compared to the oral contraceptive.
Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring.Timmer, CJ., Mulders, TM.[2018]
A new ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed to accurately measure etonogestrel (ENG) levels in serum, which is crucial for understanding its pharmacokinetics in contraceptive use.
The method demonstrated high sensitivity with detection limits as low as 25 pg/mL and was successfully applied to assess ENG levels in patients, helping to determine the efficacy of contraceptive implants and the need for removal.
A UPLC-MS/MS method for therapeutic drug monitoring of etonogestrel.Thomas, T., Petrie, K., Shim, J., et al.[2021]
In a study of 152 postpartum patients, early insertion of the Implanon contraceptive implant did not significantly affect the duration of lochia, with both treatment and control groups experiencing similar median durations of around 25 days.
Out of the women who had Implanon inserted, 17.7% experienced prolonged or intermittent vaginal bleeding beyond 50 days postpartum, leading to their implant removal, indicating a potential side effect of the contraceptive method.
A prospective cohort study of early postpartum etonogestrel implant (Implanon®) use and its effect on duration of lochia.Dobromilsky, KC., Allen, PL., Raymond, SH., et al.[2019]

References

Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. [2018]
A UPLC-MS/MS method for therapeutic drug monitoring of etonogestrel. [2021]
A prospective cohort study of early postpartum etonogestrel implant (Implanon®) use and its effect on duration of lochia. [2019]
Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. [2007]
[Safety profile of etonogestrel contraceptive implant (Nexplanon® and Implanon®) reported in France]. [2017]
Delayed-type hypersensitivity reaction against Nexplanon®. [2014]
Bioavailability and bioequivalence of etonogestrel from two oral formulations of desogestrel: Cerazette and Liseta. [2022]
Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. [2022]
Neuropathy associated with etonogestrel implant insertion. [2022]
Ultrasound localisation and removal of non-palpable Implanon implants. [2022]