Contraceptive Implant for Sickle Cell Disease
(SCD CURE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Pennsylvania
No Placebo Group
Prior Safety Data
Approved in 10 Jurisdictions
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.
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.
12345What 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.
12567Is 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.
238910Eligibility 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.
+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
+3 more
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Penn Medicine University CityPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. [2018]To assess the pharmacokinetics of etonogestrel and ethinylestradiol released from a novel combined contraceptive vaginal ring (NuvaRing) releasing etonogestrel 120microg and ethinylestradiol 15 microg per day and compare them with those of a combined oral contraceptive containing desogestrel 150 microg/ethinylestradiol 30 microg (DSG/EE COC).
A UPLC-MS/MS method for therapeutic drug monitoring of etonogestrel. [2021]Etonogestrel (ENG) is a progestin used in the contraceptive vaginal ring NuvaRing and the subdermal implant Implanon. A sensitive method for measuring ENG is useful for further investigating the progestin's pharmacokinetics with these alternative contraceptive formulations and generating important information about possible continued efficacy or potential failure to remove the subdermal implant.
A prospective cohort study of early postpartum etonogestrel implant (Implanon®) use and its effect on duration of lochia. [2019]Etonogestrel (ENG) implants (Implanon(®)/Nexplanon(®)/Implanon NXT(®)) are employed as contraception in early postpartum patients. Follow-up is often not conducted by the hospital prescriber. Little is known about duration of lochia, in a modern setting, and even less is known about the effect of ENG implants on lochia.
Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. [2007]This study compared metabolic, hormonal and lipid profiles before and during use of a contraceptive vaginal ring (RING) releasing 15 mcg ethinyl estradiol (EE) and 120 mcg etonogestrel per day NuvaRing, Organon USA Inc., Roseland, NJ versus a low-dose oral contraceptive (PILL) containing 20 mcg EE and 100 mcg levonorgestrel daily (Aviane, Barr Pharmaceuticals Inc., Pomona, NY).
[Safety profile of etonogestrel contraceptive implant (Nexplanon® and Implanon®) reported in France]. [2017]Label="OBJECTIVES" NlmCategory="OBJECTIVE">The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon® and Nexplanon®).
Delayed-type hypersensitivity reaction against Nexplanon®. [2014]Nexplanon® is an etonogestrel implant with a long-acting contraceptive effect. Although several studies underlined its safety profile, its implant can rarely lead to moderate or severe adverse event. Here, we presented a case of delayed-type hypersensitivity reaction against Nexplanon® that resolved after its removal.
Bioavailability and bioequivalence of etonogestrel from two oral formulations of desogestrel: Cerazette and Liseta. [2022]In a three-period cross-over study with 24 healthy young females (study part 1), the bioavailability of etonogestrel (3-ketodesogestrel) was determined after a single oral dose of two Cerazette tablets (each containing 75 microg desogestrel), one Liseta tablet (containing 150 microg desogestrel and 1.5 mg 17beta-estradiol), and an intravenous dose of 150 microg etonogestrel. Etonogestrel serum levels from 23 subjects could be analysed by radio-immunoassay. The geometric mean bioavailability of etonogestrel from Cerazette and Liseta tablets was 0.79 and 0.82, with 95% confidence intervals of 0.73-0.86 and 0.76-0.88, respectively. Also, the oral formulations were found to be bioequivalent. Subsequently, the single-dose pharmacokinetic parameters of etonogestrel from Cerazette tablets were compared with those after multiple dosing of one Cerazette tablet once daily for 7 days, in a subgroup of 12 subjects (study part 2). A steady state was observed from the fourth day of daily dosing onwards, with time-invariant parameters except for a 14% lower dose-normalised AUC. The least-squares geometric means of the elimination half-life of etonogestrel were approximately 30 h for the three single-dose treatments in study part 1, as well as for the single- and multiple-dose treatments of Cerazette in study part 2, without differences between groups.
Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. [2022]The etonogestrel (ENG) implant Implanon is a progestin-only contraceptive that provides effective contraception for up to 3 years. A new radiopaque ENG implant has been developed to extend the diagnostic modalities of Implanon and a next-generation applicator (NGA) was designed to facilitate correct subdermal insertion of Implanon.
Neuropathy associated with etonogestrel implant insertion. [2022]The etonogestrel contraceptive implant (Implanon®) is an effective, long-acting subdermal method of hormonal contraception for women.
Ultrasound localisation and removal of non-palpable Implanon implants. [2022]Implanon is the trade name for a contraceptive implant that releases etonogestrel over a 3-year period. The rod is inserted into the subdermis of the upper arm. The implant should be palpable and easily removed through a small incision.