Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Depot Medroxyprogesterone Acetate (Depo-Provera), Contraception, Vaso-Occlusive Pain
Brief 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.
Interventions
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Sponsors
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Female, aged 18-50 years old 3. Diagnosis of sickle cell disease (SS, SB0,SB+,SC) 4. Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months 5. At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe 6. Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study. 7. Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days. 8. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months 9. Access to a device with text-messaging capability 10. Must be able to read and understand English 11. Willing to comply with study procedures
Exclusion criteria
1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease 2. History of VTE or stroke 3. Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation 4. Current use of hormonal contraception or the copper intrauterine device 5. Current pregnancy or pregnancy within the last 6 months 6. Current lactation 7. Polycystic ovary syndrome or irregular periods 8. Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit 9. Has a history or current evidence of any condition, therapy, or other circumstance that in the opinion of the investigator exposes the participant to risk through participating in the trial, may confound the results of the trial, or could interfere with participation for the full duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of acute vaso-occlusive episodes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | 6 months | C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| Hemoglobin | 6 months | Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| Reticulocyte count | 6 months | Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| Platelet count | 6 months | Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| Fetal hemoglobin | 6 months | Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| Bilirubin | 6 months | Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| D-dimer | 6 months | D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
| von Willebrand factor | 6 months | von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
Countries
United States
Contacts
CONTACTArden McAllister, MPH
PRINCIPAL_INVESTIGATORAndrea Roe, MD MPH
University of Pennsylvania
Outcome results
None listed