Klinische en biomarkereffecten van depotmedroxyprogesteronacetaat bij vrouwen met sikkelcelziekte (SCD Depo)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Arden McAllister, MPH
- Telefoonnummer: 267-785-8044
- E-mail: arden.mcallister@pennmedicine.upenn.edu
Studie Locaties
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30322
- Nog niet aan het werven
- Emory University
-
Contact:
- Hailly Butler
- Telefoonnummer: 404-712-8895
- E-mail: hailly.butler@emory.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Werving
- Children's Hospital of Philadelphia
-
Contact:
- Kandace Gollomp
- Telefoonnummer: 215-590-3535
- E-mail: gollompk@chop.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
- 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
- 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.
- Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.
- Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
- Access to a device with text-messaging capability
- Must be able to read and understand English
- Willing to comply with study procedures
Exclusion Criteria:
- 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
- Current pregnancy or pregnancy within the last 6 months
- Current lactation
- Polycystic ovary syndrome or irregular periods
- Blood pressure >= 160 systolic or >=100 diastolic at screening visit
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Depot Medroxyprogesterone Acetate (Depo-Provera)
All participants will receive a 150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension after a 3-month baseline with no hormonal contraception. |
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Frequency of acute vaso-occlusive episodes
Tijdsspanne: 6 months
|
The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. 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 one week without pain. |
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
C-reactive protein
Tijdsspanne: 6 months
|
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Hemoglobin
Tijdsspanne: 6 months
|
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Reticulocyte count
Tijdsspanne: 6 months
|
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Platelet count
Tijdsspanne: 6 months
|
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Fetal hemoglobin
Tijdsspanne: 6 months
|
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Bilirubin
Tijdsspanne: 6 months
|
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
D-dimer
Tijdsspanne: 6 months
|
D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
von Willebrand factor
Tijdsspanne: 6 months
|
von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Pain intensity
Tijdsspanne: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 1a Numeric Rating Scale, comparing baseline and intervention phases. |
6 months
|
|
Pain intensity
Tijdsspanne: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 3a scale, comparing baseline and intervention phases. |
6 months
|
|
Pain interference
Tijdsspanne: 6 months
|
PROMIS pain interference 8a scale, comparing baseline and intervention phases. |
6 months
|
|
Number of vaso-occlusive pain days
Tijdsspanne: 6 months
|
Number of vaso-occlusive pain days as measured in the study diary, comparing baseline and intervention phases. |
6 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Andrea Roe, MD MPH, University of Pennsylvania
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 857039
- 1R01HL175726-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
After the study is completed, the de-identified, archived data will be transmitted to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for use by other researchers including those outside of the study.
IPD-tijdsbestek voor delen
Data will be made available starting 6 months after publication. There is no planned end date.
IPD-toegangscriteria voor delen
Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
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