Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

NCT03744507 | Completed

• 2 other identifiers: MVT-601-0342018-001367-22
• Study Type: observational
• Target: 660
• Locations: 7 countries
• Sites: 63

Brief Summary

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

Conditions

Uterine Fibroid; Endometriosis

Keywords

Uterine leiomyoma; Uterine fibroids; Heavy menstrual bleeding; Menorrhagia; Endometriosis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Healthcare utilization for uterine fibroids or endometriosis

  over 52 weeks

• Frequency of concomitant medication use.

  over 52 weeks

• Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).

  from Baseline up to Week 52

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with endometriosis or with uterine fibroids

You may qualify if:

• 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:
• Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
• Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
• Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Myovant Sciences GmbH: lead

Study Sites (63)

Mobile

Mobile, Alabama, 36608, United States

Location

Mesa

Mesa, Arizona, 85215, United States

Location

Huntington Beach

Huntington Beach, California, 92647, United States

Location

Palos Verdes Estates

Palos Verdes Estates, California, 90274, United States

Location

Denver

Denver, Colorado, 80209, United States

Location

United States, Colorado

Denver, Colorado, 80211, United States

Location

Aventura

Aventura, Florida, 33180, United States

Location

Jupiter

Jupiter, Florida, 33458, United States

Location

Loxahatchee

Loxahatchee Groves, Florida, 33470, United States

Location

Margate

Margate, Florida, 33063, United States

Location

Miami

Miami, Florida, 33126, United States

Location

Orange City

Orange City, Florida, 32763, United States

Location

Orlando

Orlando, Florida, 32835, United States

Location

Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

Location

Sarasota

Sarasota, Florida, 34239, United States

Location

West Palm Beach

West Palm Beach, Florida, 33409, United States

Location

Atlanta

Atlanta, Georgia, 30328, United States

Location

Decatur

Decatur, Georgia, 30034, United States

Location

Norcross

Norcross, Georgia, 30093, United States

Location

Oak Brook

Oak Brook, Illinois, 60523, United States

Location

Towson

Towson, Maryland, 21204, United States

Location

Canton

Canton, Michigan, 48187, United States

Location

Durham

Durham, North Carolina, 27713, United States

Location

Raleigh

Raleigh, North Carolina, 27607, United States

Location

Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Columbus

Columbus, Ohio, 43231, United States

Location

Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Memphis

Memphis, Tennessee, 38119, United States

Location

Memphis

Memphis, Tennessee, 38120, United States

Location

Beaumont

Beaumont, Texas, 77702, United States

Location

Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston

Houston, Texas, 77030, United States

Location

Houston

Houston, Texas, 77054, United States

Location

San Antonio

San Antonio, Texas, 78258, United States

Location

Sugar Land

Sugar Land, Texas, 77479, United States

Location

Webster

Webster, Texas, 77598, United States

Location

Virginia Beach

Virginia Beach, Virginia, 23456, United States

Location

Blacktown

Blacktown, New South Wales, 2148, Australia

Location

Kanwal

Kanwal, New South Wales, 2259, Australia

Location

Sherwood

Sherwood, Queensland, 4075, Australia

Location

Nedlands

Nedlands, Western Australia, 6009, Australia

Location

Santiago

Santiago, 7510186, Chile

Location

Santiago

Santiago, 8320165, Chile

Location

Santiago

Santiago, 8360160, Chile

Location

Pisek

Písek, Jihočeský kraj, 39701, Czechia

Location

Praha 10

Prague, Prague, 10034, Czechia

Location

Olomouc

Olomouc, Severomoravsky KRAJ, 772 00, Czechia

Location

Tbilisi

Tbilisi, Borjomi, 159, Georgia

Location

Tbilisi

Tbilisi, 159, Georgia

Location

Gyula

Gyula, Bekes County, 5700, Hungary

Location

Kecskemet

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Szeged

Szeged, Csongrád megye, 6725, Hungary

Location

Debrecen

Debrecen, Hajdú-Bihar, 4024, Hungary

Location

Skorzewo

Skórzewo, Greater Poland Voivodeship, 60185, Poland

Location

Lublin

Lublin, Lublin Voivodeship, 20064, Poland

Location

Lublin

Lublin, Lublin Voivodeship, 20093, Poland

Location

Warszawa

Warsaw, Masovian Voivodeship, 2066, Poland

Location

Warszawa

Warsaw, Masovian Voivodeship, 2929, Poland

Location

Biaystok

Bialystok, Podlaskie Voivodeship, 15224, Poland

Location

Biaystok

Bialystok, Podlaskie Voivodeship, 15464, Poland

Location

Katowice

Katowice, Silesian Voivodeship, 40081, Poland

Location

Katowice

Katowice, Silesian Voivodeship, 40301, Poland

Location

Szczecin

Szczecin, West Pomeranian Voivodeship, 71434, Poland

Location

MeSH Terms

Conditions

Leiomyoma; Endometriosis; Myofibroma; Menorrhagia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Uterine Hemorrhage; Uterine Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: August 3, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (4); US (37); CL (3); AU (4); CZ (3); GE (2); PL (10)