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NCT05862272 Clinical Trial

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

Endometriosis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05862272
Other study ID # MVT-601A-006
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 14, 2023
Est. completion date September 2030

Study information
Verified date March 2024
Source Sumitomo Pharma Switzerland GmbH
Contact Clinical Trials at Myovant
Phone 650-278-8743
Email ClinicalTrials@Myovant.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Relugolix Combination Tablet
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.
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Sponsors (1)
Lead Sponsor Collaborator
Sumitomo Pharma Switzerland GmbH

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline up to Month 48
Primary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48 and 12 months post treatment
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