Effects of the Contraceptive Implant in Women With Sickle Cell Disease (NCT05730205) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effects of the Contraceptive Implant in Women With Sickle Cell Disease
United States22 participantsStarted 2023-08-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female aged 18-45
* Diagnosis of sickle cell disease (SS, SB 0, SB+, SC)
* Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
* Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study.
* Access to a device with text messaging capability
* Must be able to read and understand English
* Willing to comply with study procedures
Exclusion Criteria:
* Use of Depo Provera in the past 6 months
* Changes to sickle cell medications in the past 3 months
* Regular blood transfusions
* History of hematopoeitic stem cell transplantation
* Contraindications to use of Nexplanon device as per clinical standards (not including history of venous thromboemblosim \[VTE\])
* Currently pregnant or pregnant within the last month or seeking to become pregnant
* Currently breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.