겸상적혈구질환 여성에서 Depot Medroxyprogesterone Acetate의 임상 및 바이오마커 효과 (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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Arden McAllister, MPH
- 전화번호: 267-785-8044
- 이메일: arden.mcallister@pennmedicine.upenn.edu
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- 아직 모집하지 않음
- Emory University
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연락하다:
- Hailly Butler
- 전화번호: 404-712-8895
- 이메일: hailly.butler@emory.edu
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- Children's Hospital of Philadelphia
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연락하다:
- Kandace Gollomp
- 전화번호: 215-590-3535
- 이메일: gollompk@chop.edu
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of acute vaso-occlusive episodes
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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C-reactive protein
기간: 6 months
|
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
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Hemoglobin
기간: 6 months
|
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
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Reticulocyte count
기간: 6 months
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Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
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Platelet count
기간: 6 months
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Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Fetal hemoglobin
기간: 6 months
|
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
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Bilirubin
기간: 6 months
|
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
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D-dimer
기간: 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
기간: 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
기간: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 1a Numeric Rating Scale, comparing baseline and intervention phases. |
6 months
|
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Pain intensity
기간: 6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 3a scale, comparing baseline and intervention phases. |
6 months
|
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Pain interference
기간: 6 months
|
PROMIS pain interference 8a scale, comparing baseline and intervention phases. |
6 months
|
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Number of vaso-occlusive pain days
기간: 6 months
|
Number of vaso-occlusive pain days as measured in the study diary, comparing baseline and intervention phases. |
6 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Andrea Roe, MD MPH, University of Pennsylvania
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 857039
- 1R01HL175726-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Data will be made available starting 6 months after publication. There is no planned end date.
IPD 공유 액세스 기준
Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .