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

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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…

Phase 31.000 Teilnehmende gesucht120 Studienzentren1 Land

Kategorien

Geburtshilfe und Gynäkologie78%Onkologie7%Nephrologie und Urologie7%Dermatologie7%

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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.

Present: Registered before enrolment beganFirst posted 2023-05-17; recorded start 2023-08-14
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (Sumitomo Pharma Switzerland GmbH)
Not stated: 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.

Zusammenfassung

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.

Erkrankungen

Uterine Fibroids
Endometriosis

Eignung

Eignung
Geschlecht	Weiblich
Alter	18 Years – 50 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	1.000 Teilnehmende gesucht

Sponsor und Mitwirkende

Sumitomo Pharma Switzerland GmbH Sponsor

Studienarme und Interventionen

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

Interventionen

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

Endpunkte

Primärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Primärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 months and 12 months post treatment
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48
Sekundärer Endpunkt
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.
Zeitrahmen Baseline up to Month 48 and 12 months post treatment

Daten

Daten
Startdatum	14. August 2023 (tatsächlich)
Primärer Abschluss	1. Juli 2029 (geschätzt)
Abschluss	1. September 2030 (geschätzt)
Erstveröffentlichung	17. Mai 2023 (tatsächlich)
Zuletzt aktualisiert	6. August 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

120 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Annandale	Annandale	Virginia	Rekrutiert
Arlington	Arlington	Texas	Rekrutiert
Atlanta	Atlanta	Georgia	Rekrutiert
Atlanta	Atlanta	Georgia	Rekrutiert
Aurora	Aurora	Colorado	Rekrutiert
Aventura	Aventura	Florida	Rekrutiert
Baltimore	Baltimore	Maryland	Rekrutiert
Bay City	Bay City	Michigan	Rekrutiert
Bluffton	Bluffton	South Carolina	Rekrutiert
Burbank	Burbank	California	Rekrutiert
Canoga Park	Canoga Park	California	Rekrutiert
Chandler	Chandler	Arizona	Rekrutiert
Chattanooga	Chattanooga	Tennessee	Rekrutiert
Chicago	Chicago	Illinois	Rekrutiert
Chicago	Chicago	Illinois	Rekrutiert
Cincinnati	Cincinnati	Ohio	Rekrutiert
Cleveland	Cleveland	Ohio	Rekrutiert
College Park	College Park	Georgia	Rekrutiert
Columbus	Columbus	Ohio	Rekrutiert
Columbus	Columbus	Ohio	Rekrutiert
Covington	Covington	Louisiana	Rekrutiert
Dallas	Dallas	Texas	Rekrutiert
Dallas	Dallas	Texas	Rekrutiert
Deland	DeLand	Florida	Rekrutiert
Dearborn Heights	Dearborn Heights	Michigan	Rekrutiert
Detroit	Detroit	Michigan	Rekrutiert
Dublin	Dublin	Ohio	Rekrutiert
Durham	Durham	North Carolina	Rekrutiert
Encinitas	Encinitas	California	Rekrutiert
Englewood	Englewood	Ohio	Rekrutiert
Erie	Erie	Pennsylvania	Rekrutiert
Fayetteville	Fayetteville	Georgia	Rekrutiert
Fort Worth	Fort Worth	Texas	Rekrutiert
Galveston	Galveston	Texas	Rekrutiert
Grand Island	Grand Island	Nebraska	Rekrutiert
Greenville	Greenville	South Carolina	Rekrutiert
Greenwood Village	Greenwood Village	Colorado	Rekrutiert
Hialeah	Hialeah	Florida	Rekrutiert
Houston	Houston	Texas	Rekrutiert
Houston	Houston	Texas	Rekrutiert
Houston	Houston	Texas	Rekrutiert
Houston	Houston	Texas	Rekrutiert
Idaho Falls	Idaho Falls	Idaho	Rekrutiert
Idaho Falls	Idaho Falls	Idaho	Rekrutiert
Inglewood	Inglewood	California	Rekrutiert
Jackson	Jackson	Tennessee	Rekrutiert
Kissimmee	Kissimmee	Florida	Rekrutiert
Lake Worth	Lake Worth	Florida	Rekrutiert
Lakewood	Lakewood	Colorado	Rekrutiert
Las Vegas	Las Vegas	Nevada	Rekrutiert

70 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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