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NCT05862272ClinicalTrials.gov

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding…

المرحلة 3مطلوب 1,000 مشارك120 موقعاًدولة واحدة

الفئات

التوليد وأمراض النساء78%علم الأورام7%الكلى والمسالك البولية7%الأمراض الجلدية7%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2023-05-17; recorded start 2023-08-14
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (Sumitomo Pharma Switzerland GmbH)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 120 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 120 sites.

How this score is built
  • Enrolment30/40

    1,000 participants (target)

  • Site count23/25

    120 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 86 months

  • Sponsor scale2/10

    Sumitomo Pharma Switzerland GmbH has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.

A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol \[E2\] 1 mg/norethindrone acetate \[NETA\] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis. Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months. A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol. Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.

الحالات

  • Uterine Fibroids
  • Endometriosis

الأهلية

الجنسأنثى
الأعمار18 Years – 50 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Key Inclusion Criteria: * Is a premenopausal woman, 18 to 50 years of age (inclusive); * A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or * A diagnosis of endometriosis that is associated with moderate to severe pain.; * If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception. * Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 \[NCT04756037; SERENE\]); * In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements; * Has a body mass index ≥ 18 kg/m\^2. Key Exclusion Criteria: * Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur * Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck): 1. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age) 2. For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline; * Screening 25-OH vitamin D level \< 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to \< 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period); * Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) \< 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed; * History of low trauma (fragility) fracture. * Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations; * Prior use of depot-medroxyprogesterone acetate for a treatment period \> 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for \> 12 months total (unless directly entering from MVT-601-050 \[NCT04756037; SERENE\]); * Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery); * Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention * History of organ transplantation or history of bone marrow * BIRADS ≥ 3 Mammogram at entry (or within the past 6 months). * Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV * Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data. * Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصغير منطبق
نموذج التدخّلSINGLE_GROUP
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,000 مشارك

الجهة الراعية والمتعاونون

  • Sumitomo Pharma Switzerland GmbH الجهة الراعية

الأذرع والتدخلات

  • Relugolix Combination TabletEXPERIMENTAL

    Participants will receive relugolix combination therapy orally once daily for 48 months.

التدخلات

  • دواء Relugolix Combination Tablet

    A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    الإطار الزمني Baseline up to Month 48

  2. مقياس النتيجة الأولي

    Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    الإطار الزمني Baseline up to Month 48

  3. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    الإطار الزمني Baseline up to Month 48

  4. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    الإطار الزمني Baseline up to Month 48

  5. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  6. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  7. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني Baseline up to Month 48

  8. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني Baseline up to Month 48

  9. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  10. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  11. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  12. مقياس النتيجة الثانوي

    Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  13. مقياس النتيجة الثانوي

    Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  14. مقياس النتيجة الثانوي

    Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  15. مقياس النتيجة الثانوي

    Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    الإطار الزمني 6 months and 12 months post treatment

  16. مقياس النتيجة الثانوي

    Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.

    Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population. The treatment-emergent period will be defined as the period of time from the date of the first dose of the study drug through 14 days after the last dose of study drug, or the date of initiation of another investigational agent or hormonal therapy affecting the hypothalamic-pituitary gonadal axis or surgical intervention for uterine fibroids or for endometriosis, whichever occurs first.

    الإطار الزمني Baseline up to Month 48

  17. مقياس النتيجة الثانوي

    Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.

    Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population. All adverse events will be coded to preferred term and system organ class using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0 or higher. The incidence of fractures will also be summarized by anatomical sites and whether the fracture qualifies as a fragility fracture. A participant reporting the same adverse event more than once is counted once, and at the maximum severity or strongest relationship to study drug treatment when calculating incidence.

    الإطار الزمني Baseline up to Month 48 and 12 months post treatment

التواريخ

تاريخ البدء14 أغسطس 2023 (فعلي)
الإتمام الأولي1 يوليو 2029 (تقديري)
الإتمام1 سبتمبر 2030 (تقديري)
أول نشر17 مايو 2023 (فعلي)
آخر تحديث6 أغسطس 2025
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2025

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

120 موقعاً قيد التجنيد

United States

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يُدرَج 70 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05862272