Klinische und Biomarker-Wirkungen von Depot-Medroxyprogesteronacetat bei Frauen mit Sichelzellenanämie (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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
- Name: Arden McAllister, MPH
- Telefonnummer: 267-785-8044
- E-Mail: arden.mcallister@pennmedicine.upenn.edu
Studienorte
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Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30322
- Noch keine Rekrutierung
- Emory University
-
Kontakt:
- Hailly Butler
- Telefonnummer: 404-712-8895
- E-Mail: hailly.butler@emory.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Rekrutierung
- Children's Hospital of Philadelphia
-
Kontakt:
- Kandace Gollomp
- Telefonnummer: 215-590-3535
- E-Mail: gollompk@chop.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency of acute vaso-occlusive episodes
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
C-reactive protein
Zeitfenster: 6 months
|
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Hemoglobin
Zeitfenster: 6 months
|
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Reticulocyte count
Zeitfenster: 6 months
|
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Platelet count
Zeitfenster: 6 months
|
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Fetal hemoglobin
Zeitfenster: 6 months
|
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Bilirubin
Zeitfenster: 6 months
|
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
D-dimer
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 1a Numeric Rating Scale, comparing baseline and intervention phases. |
6 months
|
|
Pain intensity
Zeitfenster: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 3a scale, comparing baseline and intervention phases. |
6 months
|
|
Pain interference
Zeitfenster: 6 months
|
PROMIS pain interference 8a scale, comparing baseline and intervention phases. |
6 months
|
|
Number of vaso-occlusive pain days
Zeitfenster: 6 months
|
Number of vaso-occlusive pain days as measured in the study diary, comparing baseline and intervention phases. |
6 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Andrea Roe, MD MPH, University of Pennsylvania
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 857039
- 1R01HL175726-01 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Data will be made available starting 6 months after publication. There is no planned end date.
IPD-Sharing-Zugriffskriterien
Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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