New study tracks how sickle cell drug affects puberty and fertility
NCT ID NCT07116772
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
The SAFE study is a long-term research project following 250 adolescents and young adults with sickle cell anemia. It aims to understand how the medicine hydroxyurea affects growth, puberty, and the ability to have children. Researchers will also compare pregnancy outcomes between those who take hydroxyurea and those who do not.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hydroxyurea
- What this could lead to
- If successful, this study could clarify how hydroxyurea affects growth, puberty, and fertility in people with sickle cell anemia, helping guide safer long-term use.
- What could go wrong
- This is an observational study, not a treatment trial. It will not test new therapies or directly improve outcomes. Results may take years and may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.
- Ages
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8 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with documented sickle cell anemia (SCA). * At least 8 years of age at the time of enrollment. * Enrolled on the EXTEND or SACRED study. * Provide informed consent. * Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits. Exclusion Criteria: * Currently taking part in another treatment study (not EXTEND or SACRED). * Has received other treatments for sickle cell disease in the past 6 months.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Sickle cell anemia are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Buganda Medical Centre
RECRUITINGMwanza, Tanzania
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Caribbean Institute for Health Research, University of West Indies
RECRUITINGKingston, Jamaica
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Centro de Obstetricia y Ginecologia
RECRUITINGSanto Domingo, Dominican Republic
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Other studies related to the condition(s) this trial covers.
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- New sickle cell drug candidate enters first human tests
- New study tracks sickle cell Drug's effects on moms and babies
- New stem cell transplant could help sickle cell patients without a perfect donor match
- One donor, two transplants: could this end lifelong Anti-Rejection drugs?
- Simple quiz may reveal hidden brain struggles in sickle cell patients