Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Female, aged 18-50 years old
Diagnosis of sickle cell disease (SS, SB0,SB+,SC)
Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
Disqualifiers
Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
History of VTE or stroke
Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation
Current use of hormonal contraception or the copper intrauterine device
Trial design
Design model
Single group
Treatments tested in this trial
Depot medroxyprogesterone acetate (DMPA)
Drug150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Depot Medroxyprogesterone Acetate (Depo-Provera)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of acute vaso-occlusive episodes
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 monthsSecondary outcomes
1
C-reactive protein
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame
6 months2
Hemoglobin
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame
6 months3
Reticulocyte count
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame
6 months4
Platelet count
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Emory University
Collaborator
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov