Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862272
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-05-08
Brief Title:
A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis
Sponsor:
Sumitomo Pharma Switzerland GmbH
Organization:
Sumitomo Pharma Switzerland GmbH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 mgestradiol E2 1 mgnorethindrone acetate NETA 05 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None