자궁근종에 대한 레트로졸 처방 (PLUM)
자궁 근종 치료를 위한 레트로졸: 무작위, 위약 대조 시험
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Lisa Abinanti
- 이메일: lisa.abinanti@ucsf.edu
연구 연락처 백업
- 이름: Study Coordinator
- 전화번호: (510) 788-0545
- 이메일: plumstudy@ucsf.edu
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90095
- 모병
- University of California, Los Angeles
-
연락하다:
- Study Coordinator
- 전화번호: 310-794-3467
- 이메일: sfkhan@mednet.ucla.edu
-
수석 연구원:
- Ram Parvataneni, MD
-
수석 연구원:
- Jacqueline Fahey, MD
-
San Francisco, California, 미국, 94115
- 모병
- University of California, San Francisco
-
수석 연구원:
- Vanessa L Jacoby, MD, MAS
-
수석 연구원:
- Alison Huang, MD, MAS
-
연락하다:
- Maria Tolentino
- 이메일: plumstudy@ucsf.edu
-
연락하다:
- Yulissa Oceguera-Barragan
- 이메일: plumstudy@ucsf.edu
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- 모병
- Mayo Clinic
-
연락하다:
- Clinical Research Coordinator
- 전화번호: 507-422-3984
- 이메일: Wroblewski.stacy@mayo.edu
-
수석 연구원:
- Sarah Rassier, MD
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39216
- 모병
- University of Mississippi Medical Center
-
연락하다:
- Sheila Belk
-
수석 연구원:
- Kedra Wallace, PhD
-
부수사관:
- Elizabeth Lutz, MD
-
연락하다:
- Study Coordinator
- 전화번호: 601-984-6628
- 이메일: lmelaku@umc.edu
-
-
North Carolina
-
Durham, North Carolina, 미국, 27710
- 모병
- Duke University
-
수석 연구원:
- Craig Sobolewski, MD
-
연락하다:
- Study Coordinator
- 전화번호: 919-572-7927
- 이메일: fertilityresearch@duke.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Letrozole
Oral letrozole 2.5mg/day |
Oral letrozole 2.5mg/day |
|
위약 비교기: Placebo and Letrozole
Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks |
Oral letrozole 2.5mg/day Placebo capsule |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Uterine leiomyoma-related symptom severity over 12 weeks of treatment
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Uterine leiomyoma-related quality of life over 12 weeks of treatment
기간: 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
기간: 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
기간: Baseline to 12 weeks
|
Change in total uterine volume based on pelvic ultrasound measurements |
Baseline to 12 weeks
|
|
Symptoms of heavy menstrual bleeding
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline to 12 weeks
|
Change in serum LDL cholesterol levels |
Baseline to 12 weeks
|
|
Effect of letrozole on serum estradiol levels
기간: Baseline to 12 weeks
|
Change in serum estradiol levels |
Baseline to 12 weeks
|
|
Effect of letrozole on frequency of hot flashes
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Vanessa Jacoby, MD, MAS, University of California, San Francisco
- 수석 연구원: Alison Huang, MD, MAS, University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 23-39255
- R01HD112465 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .