鎌状赤血球症の女性における酢酸メドロキシプロゲステロンのデポー剤の臨床効果とバイオマーカー効果 (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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Arden McAllister, MPH
- 電話番号：267-785-8044
- メール：arden.mcallister@pennmedicine.upenn.edu
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- まだ募集していません
- Emory University
-
コンタクト：
- Hailly Butler
- 電話番号：404-712-8895
- メール：hailly.butler@emory.edu
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- Children's Hospital of Philadelphia
-
コンタクト：
- Kandace Gollomp
- 電話番号：215-590-3535
- メール：gollompk@chop.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of acute vaso-occlusive episodes
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
C-reactive protein
時間枠：6 months
|
C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Hemoglobin
時間枠：6 months
|
Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Reticulocyte count
時間枠：6 months
|
Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Platelet count
時間枠：6 months
|
Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Fetal hemoglobin
時間枠：6 months
|
Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
Bilirubin
時間枠：6 months
|
Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention). |
6 months
|
|
D-dimer
時間枠：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
時間枠：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
時間枠：6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 1a Numeric Rating Scale, comparing baseline and intervention phases. |
6 months
|
|
Pain intensity
時間枠：6 months
|
Pain intensity, as measured by the PROMIS Pain Intensity 3a scale, comparing baseline and intervention phases. |
6 months
|
|
Pain interference
時間枠：6 months
|
PROMIS pain interference 8a scale, comparing baseline and intervention phases. |
6 months
|
|
Number of vaso-occlusive pain days
時間枠：6 months
|
Number of vaso-occlusive pain days as measured in the study diary, comparing baseline and intervention phases. |
6 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Andrea Roe, MD MPH、University of Pennsylvania
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 857039
- 1R01HL175726-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will be made available starting 6 months after publication. There is no planned end date.
IPD 共有アクセス基準
Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。