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Progestin

Contraceptive Implant for Sickle Cell Disease (SCD CURE Trial)

Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female aged 18-45
Diagnosis of sickle cell disease (SS or SB0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will measure whether a hormone implant helps reduce pain crises, improve quality of life, & blood levels in women with sickle cell disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, contraceptive implants like Nexplanon can generally cause menstrual changes, weight gain, headaches, acne, breast pain or tenderness and may also affect mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 45.
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I have been diagnosed with sickle cell disease.
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I have had at least one pain crisis a month for the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of vaso-occlusive crises

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: NexplanonActive Control1 Intervention
Group II: BaselineActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,824 Total Patients Enrolled

Media Library

Nexplanon (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT05730205 — Phase 4
Sickle Cell Disease Research Study Groups: Nexplanon, Baseline
Sickle Cell Disease Clinical Trial 2023: Nexplanon Highlights & Side Effects. Trial Name: NCT05730205 — Phase 4
Nexplanon (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05730205 — Phase 4
~3 spots leftby Feb 2025
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