SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Part of paid clinical trials in Andalusia, Alabama.

Sponsor
Myovant Sciences GmbH
Study ID
NCT03654274
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • Relugolix — DRUG
    Relugolix 40-mg tablet administered orally once daily
  • Estradiol/norethindrone acetate — DRUG
    Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily

Study Details

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

Key Dates

Start date
May 22, 2018
Status verified
Aug 2023
Primary completion
Dec 16, 2021
Completion
Jan 31, 2023

Study Design

Enrollment
802 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix plus E2/NETA
    Relugolix co-administered with E2/NETA for 80 weeks.

Primary Outcome Measure

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 [ Time Frame: Week 52 ]

Locations (60)

FacilityCityStateZIPSite coordinators
AndalusiaAndalusiaAlabama36420-
ScottsdaleScottsdaleArizona85251-
TucsonTucsonArizona85704-
TusconTucsonArizona85712-
Canoga ParkCanoga ParkCalifornia91303-
Los AngelesLos AngelesCalifornia70433-
San DiegoSan DiegoCalifornia92111-
Greenwood VillageGreenwood VillageColorado80111-
WashingtonWashington D.C.District of Columbia20036-
AventuraAventuraFlorida33180-
Fort MyersFort MyersFlorida33912-
HialeahHialeahFlorida33012-
HialeahHialeahFlorida33016-
MargateMargateFlorida33063-
MiamiMiamiFlorida33126-
MiamiMiamiFlorida33155-
SarasotaSarasotaFlorida34239-
TampaTampaFlorida33606-
AtlantaAtlantaGeorgia30312-
AtlantaAtlantaGeorgia30363-
AugustaAugustaGeorgia30909-
NorcrossNorcrossGeorgia30093-
Idaho FallsIdaho FallsIdaho83404-
OakbrookOakbrook TerraceIllinois60523-
Park RidgePark RidgeIllinois60068-
ShawneeShawnee MissionKansas66218-
MarreroMarreroLouisiana70072-
TowsonTowsonMaryland21204-
SaginawSaginawMichigan48602-
Jefferson CityJefferson CityMissouri65109-
St. LouisSt LouisMissouri63141-
OmahaOmahaNebraska68130-
Las VegasLas VegasNevada89113-
DurhamDurhamNorth Carolina27713-
New BernNew BernNorth Carolina28562-
Winston SalemWinston-SalemNorth Carolina27103-
AkronAkronOhio44313-
ColumbusColumbusOhio43235-
EnglewoodEnglewoodOhio45322-
HersheyHersheyPennsylvania17033-0850-
ColumbiaColumbiaSouth Carolina29201-
ChattanoogaChattanoogaTennessee37404-
MemphisMemphisTennessee38120-
BeaumontBeaumontTexas77702-
Corpus ChristiCorpus ChristiTexas78412-
DallasDallasTexas75231-
Fort WorthFort WorthTexas76104-
HoustonHoustonTexas77030-
HoustonHoustonTexas77054-
IrvingIrvingTexas75062-
San AntonioSan AntonioTexas78258-
Sugar LandSugar LandTexas77479-
WebsterWebsterTexas77598-
Salt Lake CitySalt Lake CityUtah84102-
Salt Lake CitySalt Lake CityUtah84107-
Salt Lake CitySalt Lake CityUtah84124-
NorfolkNorfolkVirginia23507-
RichmondRichmondVirginia23235-
Virginia BeachVirginia BeachVirginia23502-
SeattleSeattleWashington98105-

Find similar trials in Andalusia, AL

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Andalusia· Andalusia, ALScottsdale· Scottsdale, AZTucson· Tucson, AZTuscon· Tucson, AZCanoga Park· Canoga Park, CALos Angeles· Los Angeles, CA

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