子宮筋腫に対するレトロゾールの処方 (PLUM)
子宮筋腫治療のためのレトロゾール: 無作為化プラセボ対照試験
The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.
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：Lisa Abinanti
- メール：lisa.abinanti@ucsf.edu
研究連絡先のバックアップ
- 名前：Study Coordinator
- 電話番号：(510) 788-0545
- メール：plumstudy@ucsf.edu
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90095
- 募集
- University of California, Los Angeles
-
コンタクト：
- Study Coordinator
- 電話番号：310-794-3467
- メール：sfkhan@mednet.ucla.edu
-
主任研究者：
- Ram Parvataneni, MD
-
主任研究者：
- Jacqueline Fahey, MD
-
San Francisco、California、アメリカ、94115
- 募集
- University of California, San Francisco
-
主任研究者：
- Vanessa L Jacoby, MD, MAS
-
主任研究者：
- Alison Huang, MD, MAS
-
コンタクト：
- Maria Tolentino
- メール：plumstudy@ucsf.edu
-
コンタクト：
- Yulissa Oceguera-Barragan
- メール：plumstudy@ucsf.edu
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic
-
コンタクト：
- Clinical Research Coordinator
- 電話番号：507-422-3984
- メール：Wroblewski.stacy@mayo.edu
-
主任研究者：
- Sarah Rassier, MD
-
-
Mississippi
-
Jackson、Mississippi、アメリカ、39216
- 募集
- University of Mississippi Medical Center
-
コンタクト：
- Sheila Belk
-
主任研究者：
- Kedra Wallace, PhD
-
副調査官：
- Elizabeth Lutz, MD
-
コンタクト：
- Study Coordinator
- 電話番号：601-984-6628
- メール：lmelaku@umc.edu
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- 募集
- Duke University
-
主任研究者：
- Craig Sobolewski, MD
-
コンタクト：
- Study Coordinator
- 電話番号：919-572-7927
- メール：fertilityresearch@duke.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:
- At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)
- Female sex, based on sex identified on their birth certificate (no other gender requirements)
- Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months
- Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
- Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline
- Has had a menstrual period in the past 3 months (90 days)
- Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)
Exclusion Criteria:
- Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year
- Screening pelvic imaging indicating only one, sole leiomyoma <2 cm in maximum diameter
- Any submucosal leiomyoma that is >50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)
- Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
- Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks
- Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
- Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
- Screening serum hemoglobin <8 g/dL, or history of blood transfusion in the last 12 weeks (indicating severe anemia)
- Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg/dL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women)
- Screening serum estradiol level <30 pg/mL (consistent with postmenopausal status)
- For women aged 45 years or older only: irregular menstrual cycles (menstrual cycles <21 days or >38 days between periods), prolonged menstrual bleeding (bleeding >14 days), or bleeding in between menstrual periods, unless already evaluated by a clinician to discuss endometrial biopsy (uterine biopsy) to rule out endometrial hyperplasia.
- History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score < -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss)
- History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole
- Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention)
- Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion
- Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system
- Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule
- Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks
- Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks
- Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks
- Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)
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：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Letrozole
Oral letrozole 2.5mg/day |
Oral letrozole 2.5mg/day |
|
プラセボコンパレーター：Placebo and Letrozole
Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks |
Oral letrozole 2.5mg/day Placebo capsule |
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 |
|---|---|---|
|
Uterine leiomyoma-related symptom severity over 12 weeks of treatment
時間枠：Baseline to 12 weeks
|
Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Symptom Severity Scale (SSS) score [Range 8-40 with higher score indicating worse symptoms and worse outcomes] |
Baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Uterine leiomyoma-related quality of life over 12 weeks of treatment
時間枠：Baseline to 12 weeks
|
Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Health-Related QOL component score [Range 29-145 points, with higher score indicating better QoL and better outcomes] |
Baseline to 12 weeks
|
|
Total leiomyoma volume over 12 weeks of treatment
時間枠：Baseline to 12 weeks
|
Change in total leiomyoma volume based on pelvic ultrasound measurements |
Baseline to 12 weeks
|
|
Total uterine volume over 12 weeks of treatment
時間枠：Baseline to 12 weeks
|
Change in total uterine volume based on pelvic ultrasound measurements |
Baseline to 12 weeks
|
|
Symptoms of heavy menstrual bleeding
時間枠：Baseline to 12 weeks
|
Change in symptoms of heavy menstrual bleeding based on a modified Menstrual Bleeding Questionnaire (MBQ) score [Range 0-48 with higher MBQ score indicating worse symptoms and a negative impact on quality of life] |
Baseline to 12 weeks
|
|
Improvement in Sexual Functioning
時間枠：Baseline to 12 weeks
|
Change in pelvic problems-related sexual function as measured by the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) Pelvic Problems Interference subscale score [Range 0-100 with higher scores indicating better sexual function] |
Baseline to 12 weeks
|
|
Symptoms of pelvic pain
時間枠：Baseline to 12 weeks
|
Change in pelvic pain severity/intensity "on average" (evaluated on a standard numerical rating scale of 0-10, lower rating indicating better outcomes and less pain) |
Baseline to 12 weeks
|
|
Symptoms of urogenital distress
時間枠：Baseline to 12 weeks
|
Change in distressing urogenital symptoms such as urinary frequency, urinary incontinence, and genital pain, as measured by Urogenital Distress Inventory-6 (UDI-6) [Range 0-100 with higher scores indicating higher disability/worse outcomes] |
Baseline to 12 weeks
|
|
Effect of letrozole on serum cholesterol levels
時間枠：Baseline to 12 weeks
|
Change in serum LDL cholesterol levels |
Baseline to 12 weeks
|
|
Effect of letrozole on serum estradiol levels
時間枠：Baseline to 12 weeks
|
Change in serum estradiol levels |
Baseline to 12 weeks
|
|
Effect of letrozole on frequency of hot flashes
時間枠：Baseline to 12 weeks
|
Change in frequency of vasomotor symptoms (hot flashes) as measured by the Hot Flush Rating Scale (HFRS) [no scale range but less # of reported hot flashes indicates better outcome] |
Baseline to 12 weeks
|
協力者と研究者
捜査官
- 主任研究者：Vanessa Jacoby, MD, MAS、University of California, San Francisco
- 主任研究者：Alison Huang, MD, MAS、University of California, San Francisco
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
- 23-39255
- R01HD112465 (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?
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。