Depot medroxyprogesterone acetate (DMPA)
Drug150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
NCT Number: NCT06665997
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Phase 4
Emory University, Atlanta, Georgia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Time frame: 6 months
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, with distinct episodes separated by at least 2 weeks without pain.
Time frame: 6 months
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame: 6 months
von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Acronym: SCD Depo
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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