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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

SCD CURE Trial 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.Check my eligibility

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.See study design

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.

SCD CURE Trial 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.

SCD CURE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of vaso-occlusive crises

SCD CURE Trial Design

2Treatment groups

Active Control

Group I: NexplanonActive Control1 Intervention

Group II: BaselineActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,265 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept participants who are 18 years or older?

"According to the requirements for this trial, those who wish to participate must be between 18 and 45 years of age."

Answered by AI

Does my medical profile qualify me to participate in this experiment?

"Those who have sickle cell disease and are aged between 18 to 45 may qualify for this trial. In total, 22 participants need to be recruited."

Answered by AI

Is enrollment in this clinical trial still available for participants?

"Affirmative. Clinicaltrials.gov reports that the recruitment process for this clinical trial began on June 8th, 2023 and was last updated on June 27th, 2023. 22 individuals are required at a single medical site to complete the study."

Answered by AI

Has the Food and Drug Administration certified Nexplanon's safety for use?

"There is a substantial amount of clinical data to validate Nexplanon's efficacy, so it received the maximum rating of 3."

Answered by AI

What is the current enrollment for this research study?

"Affirmative, according to the clinicaltrials.gov portal this research is still looking for participants that would join the trial. 22 volunteers are needed at one location and the initial posting date was June 8th 2023 with a last update on June 27th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of the Contraceptive Implant in Women With Sickle Cell Disease

2023. "Effects of the Contraceptive Implant in Women With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730205.

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