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NCT06665997 · ClinicalTrials.gov registry record · Phase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
A Phase 4 study of Sickle Cell Disease (SCD) and Vaso-Occlusive Pain Episode in Sickle Cell Disease, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
- 2
- Study locations
NCT06665997: Recruiting Phase 4 study of Sickle Cell Disease (SCD) and Vaso-Occlusive Pain Episode in Sickle Cell Disease, sponsored by University of Pennsylvania.
NCT06665997 is a Phase 4 study of Sickle Cell Disease (SCD) and Vaso-Occlusive Pain Episode in Sickle Cell Disease that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 65 participants, below the 398-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06665997, a Phase 4 study of Sickle Cell Disease (SCD) and Vaso-Occlusive Pain Episode in Sickle Cell Disease, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease. Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.
Primary Outcome
The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. Discrete pain episodes will be separated by at least 2 weeks from one other. During both the baseline and intervention study phases, participants will provide weekly reports via electronic survey of vaso-occlusive pain. VOE will be defined as self-reported typical SCD pain that interferes with usual daily activities or requires emergency care or hospitalization, wit
Conditions Studied
Interventions
- DRUG Depot medroxyprogesterone acetate (DMPA)
Study Locations (2)
Georgia
- Emory University - Atlanta
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2025-06-26 |
| Est. Completion | 2027-10 |
| Phase | Phase 4 |
What NCT06665997 shows while recruiting
NCT06665997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 398-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Sickle Cell Disease (SCD) appearing as the primary indexed condition, and to 1 intervention - of which Depot medroxyprogesterone acetate (DMPA) is the first listed.
NCT06665997 reports a single indexed study location in Georgia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06665997 about?
NCT06665997 is a clinical study titled "Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease". This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease. Participants in this study will be adult women with sickle cell disease who regularly experience sickle ...
What is the current status of trial NCT06665997?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2025-06-26. Estimated completion is 2027-10.
What conditions does trial NCT06665997 study?
This clinical trial studies the following conditions: Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease.
What interventions are being tested in trial NCT06665997?
The interventions under investigation include: Depot medroxyprogesterone acetate (DMPA) (DRUG).
Who is sponsoring clinical trial NCT06665997?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06665997 being conducted?
This trial has 2 study locations across Georgia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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