Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001367-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
This is a prospective observational study to characterize longitudinal BMD of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period.
Approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit (approximately 400 participants).
Since age is a strong risk factor for BMD change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix.
During the Screening/Baseline period, the participant should be assessed for eligibility, and baseline dual-energy X-ray absorptiometry (DXA) scan will be obtained. Bone densitometry (lumbar spine [L1-L4], total hip, and femoral neck) will be obtained and submitted for central reading at Baseline, Week 24, and Week 52.
Information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at Week 12 and Week 36.
Collection of adverse events in this study will be limited to protocol-specified procedure-related adverse events. Reports of pregnancy will also be collected.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterine Fibroids | Premenopausal women with uterine fibroids confirmed by an ultrasound. | ||
| Endometriosis | Premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4). | Assessed by dual-energy X-ray absorptiometry (DXA) scan. | from Baseline up to Week 52 |
| Percentage change in BMD in the femoral neck and total hip. | Assessed by DXA scan. | from Baseline up to Week 52 |
| Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip. | Assessed by dual-energy X-ray absorptiometry (DXA) scan. | from Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare utilization for uterine fibroids or endometriosis | Assessed through participants self-reporting (may be aided by review of participant medical records). Healthcare utilization includes visits to gynecologists or other primary care providers, visits to urgent care, visits to emergency department, hospitalizations, procedures (diagnostic or surgical) or changes to medication concomitant related to uterine fibroids or endometriosis. |
Not provided
Inclusion Criteria:
Is a premenopausal female 18 to 50 years old
By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles.
Has one of the following conditions:
Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.
Exclusion Criteria:
Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
Has a history of or currently has osteoporosis, or other metabolic bone disease
Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
Is currently pregnant or lactating, or intends to become pregnant during the study period
Not provided
Not provided
Not provided
Women with endometriosis or with uterine fibroids
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Mobile | Alabama | 36608 | United States | ||
| Mesa |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| over 52 weeks |
| Frequency of concomitant medication use. | Assessed through participants self-reporting. | over 52 weeks |
| Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L). | Assessed using participants responses on the EQ-5D-5L questionnaire. The EQ-5D-5L is a standardized measure of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (from 1= no problem to 5= extreme problems). | from Baseline up to Week 52 |
| Mesa |
| Arizona |
| 85215 |
| United States |
| Huntington Beach | Huntington Beach | California | 92647 | United States |
| Palos Verdes Estates | Palos Verdes Estates | California | 90274 | United States |
| Denver | Denver | Colorado | 80209 | United States |
| United States, Colorado | Denver | Colorado | 80211 | United States |
| Aventura | Aventura | Florida | 33180 | United States |
| Jupiter | Jupiter | Florida | 33458 | United States |
| Loxahatchee | Loxahatchee Groves | Florida | 33470 | United States |
| Margate | Margate | Florida | 33063 | United States |
| Miami | Miami | Florida | 33126 | United States |
| Orange City | Orange City | Florida | 32763 | United States |
| Orlando | Orlando | Florida | 32835 | United States |
| Port St. Lucie | Port Saint Lucie | Florida | 34952 | United States |
| Sarasota | Sarasota | Florida | 34239 | United States |
| West Palm Beach | West Palm Beach | Florida | 33409 | United States |
| Atlanta | Atlanta | Georgia | 30328 | United States |
| Decatur | Decatur | Georgia | 30034 | United States |
| Norcross | Norcross | Georgia | 30093 | United States |
| Oak Brook | Oak Brook | Illinois | 60523 | United States |
| Towson | Towson | Maryland | 21204 | United States |
| Canton | Canton | Michigan | 48187 | United States |
| Durham | Durham | North Carolina | 27713 | United States |
| Raleigh | Raleigh | North Carolina | 27607 | United States |
| Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Columbus | Columbus | Ohio | 43231 | United States |
| Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Memphis | Memphis | Tennessee | 38119 | United States |
| Memphis | Memphis | Tennessee | 38120 | United States |
| Beaumont | Beaumont | Texas | 77702 | United States |
| Fort Worth | Fort Worth | Texas | 76104 | United States |
| Houston | Houston | Texas | 77030 | United States |
| Houston | Houston | Texas | 77054 | United States |
| San Antonio | San Antonio | Texas | 78258 | United States |
| Sugar Land | Sugar Land | Texas | 77479 | United States |
| Webster | Webster | Texas | 77598 | United States |
| Virginia Beach | Virginia Beach | Virginia | 23456 | United States |
| Blacktown | Blacktown | New South Wales | 2148 | Australia |
| Kanwal | Kanwal | New South Wales | 2259 | Australia |
| Sherwood | Sherwood | Queensland | 4075 | Australia |
| Nedlands | Nedlands | Western Australia | 6009 | Australia |
| Santiago | Santiago | 7510186 | Chile |
| Santiago | Santiago | 8320165 | Chile |
| Santiago | Santiago | 8360160 | Chile |
| Praha 10 | Prague | Prague | 10034 | Czechia |
| Olomouc | Olomouc | Severomoravsky KRAJ | 772 00 | Czechia |
| Pisek | Písek | South Bohemian Region | 39701 | Czechia |
| Tbilisi | Tbilisi | Borjomi | 159 | Georgia |
| Tbilisi | Tbilisi | 159 | Georgia |
| Gyula | Gyula | Bekes County | 5700 | Hungary |
| Kecskemet | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Szeged | Szeged | Csongrád megye | 6725 | Hungary |
| Debrecen | Debrecen | Hajdú-Bihar | 4024 | Hungary |
| Skorzewo | Skórzewo | Greater Poland Voivodeship | 60185 | Poland |
| Lublin | Lublin | Lublin Voivodeship | 20064 | Poland |
| Lublin | Lublin | Lublin Voivodeship | 20093 | Poland |
| Warszawa | Warsaw | Masovian Voivodeship | 2066 | Poland |
| Warszawa | Warsaw | Masovian Voivodeship | 2929 | Poland |
| Biaystok | Bialystok | Podlaskie Voivodeship | 15224 | Poland |
| Biaystok | Bialystok | Podlaskie Voivodeship | 15464 | Poland |
| Katowice | Katowice | Silesian Voivodeship | 40081 | Poland |
| Katowice | Katowice | Silesian Voivodeship | 40301 | Poland |
| Szczecin | Szczecin | West Pomeranian Voivodeship | 71434 | Poland |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D004715 | Endometriosis |
| D047708 | Myofibroma |
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided