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Birth control implant may tame sickle cell pain crises

NCT ID NCT05730205

Disease control Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a progestin contraceptive implant (Nexplanon) can reduce painful sickle cell crises and improve quality of life in women aged 18-45 with sickle cell disease. Twenty-two participants will use the implant for a period and report their pain episodes. The goal is to see if this hormone-based device can help manage the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nexplanon (progestin implant)
What this could lead to
If it works, this could offer a new way to reduce painful sickle cell crises and improve daily life for women with the disease.
What could go wrong
This is a very small study (22 people) with no placebo group, so results may not be reliable or apply to everyone. The implant may not reduce pain at all.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.