SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

June 25, 2021 updated by: Myovant Sciences GmbH

SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo.

Approximately 600 women with endometriosis-associated pain will be enrolled and randomized 1:1:1 to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or Group C - placebo (N = 200 per group).

Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the double-blind period.

Eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open-label extension study where participants received relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a Follow-Up visit approximately 30 days after the participant's last dose of study drug.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
638

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000JHQ
        • Cordoba
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Ciudad de Buenos Aires
      • San Isidro, Buenos Aires, Argentina, B1642CKL
        • San Isidro
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PRB
        • Rosario
  • Belgium
      • Brussels, Belgium, 1070
        • Brussels
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Leuven
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
        • La Louvière
    • Oost-vlaanderen
      • Gent, Oost-vlaanderen, Belgium, 9000
        • Gent
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Blagoevgrad
      • Pleven, Bulgaria, 5809
        • Pleven
      • Sofia, Bulgaria, 1336
        • Sofia
      • Sofia, Bulgaria, 1606
        • Sofia
      • Stara Zagora, Bulgaria, 6003
        • Stara Zagora
      • Varna, Bulgaria, 9005
        • Varna
    • Sofiya
      • Sofia, Sofiya, Bulgaria, 1233
        • Sofia
      • Sofia, Sofiya, Bulgaria, 1431
        • Sofia
      • Sofia, Sofiya, Bulgaria, 1504
        • Sofia
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Red Deer
    • Ontario
      • Waterloo, Ontario, Canada, N2J1C4
        • Waterloo
    • Quebec
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Victoriaville
  • Czechia
      • Náchod, Czechia, 54701
        • Náchod
      • Olomouc, Czechia, 772 00
        • Olomouc
      • Praha 8 - Libeň, Czechia, 180 81
        • Praha 8 - Libeň
      • Vodňany, Czechia, 389 01
        • Vodňany
      • Vysoké Mýto, Czechia, 566 01
        • Vysoké Mýto
    • Praha
      • Praha 10, Praha, Czechia, 100 34
        • Praha 10
  • Finland
      • Oulu, Finland, 90100
        • Oulu
    • Eastern Finland
      • Kuopio, Eastern Finland, Finland, FI-70110
        • Kuopio
    • Southern Finland
      • Helsinki, Southern Finland, Finland, 00260
        • Helsinki
  • Hungary
      • Budapest, Hungary, 1135
        • Budapest
      • Budapest, Hungary, 1027
        • Budapest
      • Budapest, Hungary, 1062
        • Budapest
    • Bacs-kiskun
      • Kecskemét, Bacs-kiskun, Hungary, 6000
        • Kecskemét
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecs
    • Bekes
      • Békéscsaba, Bekes, Hungary, 5600
        • Békéscsaba
      • Gyula, Bekes, Hungary, 5700
        • Gyula
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szeged
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debrecen
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4024
        • Debrecen
      • Debrecen, Hajdu-bihar, Hungary, 4025
        • Debrecen
    • Szabolcs-szatmar-bereg
      • Nyíregyháza, Szabolcs-szatmar-bereg, Hungary, 4400
        • Nyíregyháza
  • Poland
    • Lodzkie
      • Lódz, Lodzkie, Poland, 90-602
        • Lodz
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-064
        • Lublin
      • Lublin, Lubelskie, Poland, 20-632
        • Lublin
      • Lublin, Lubelskie, Poland, 20-880
        • Lublin
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-121
        • Krakow
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-066
        • Warszawa
      • Warszawa, Mazowieckie, Poland, 02-929
        • Warszawa
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-224
        • Białystok
    • Slaskie
      • Katowice, Slaskie, Poland, 02-066
        • Katowice
      • Katowice, Slaskie, Poland, 40-081
        • Katowice
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-535
        • Poznan
      • Skórzewo, Wielkopolskie, Poland, 601-85
        • Skórzewo
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Szczecin
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Coimbra
      • Covilhã, Portugal, 6200-251
        • Covilhã
      • Lisbon, Portugal, 1069-089
        • Lisbon
      • Porto, Portugal, 4099-001
        • Porto
    • Lisboa
      • Almada, Lisboa, Portugal, 2805-267
        • Almada
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Port Elizabeth
    • Gauteng
      • Centurion, Gauteng, South Africa, 0157
        • Centurion
      • Roodepoort, Gauteng, South Africa, 1724
        • Roodepoort
    • Kwazulu-natal
      • Durban, Kwazulu-natal, South Africa, 4001
        • Durban
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Cape Town
  • Spain
      • Madrid, Spain, 28041
        • Madrid
      • Valencia, Spain, 46010
        • Valencia
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Chernivtsi
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk
      • Kharkiv, Ukraine, 61052
        • Kharkiv
      • Kiev, Ukraine, 03148
        • Kiev
      • Kiev, Ukraine, 04053
        • Kiev
      • Kiev, Ukraine, 04112
        • Kiev
      • Vinnytsya, Ukraine, 21101
        • Vinnytsya
      • Zaporizhzhya, Ukraine, 69065
        • Zaporizhzhya
      • Zaporizhzhya, Ukraine, 69068
        • Zaporizhzhya
      • Zaporizhzhya, Ukraine, 69071
        • Zaporizhzhya
      • Zaporizhzhya, Ukraine, 69663
        • Zaporizhzhya
    • Kiev
      • Kyiv, Kiev, Ukraine, 01034
        • Kyiv
    • Kiev City
      • Kyiv, Kiev City, Ukraine, 02232
        • Kyiv
      • Kyiv, Kiev City, Ukraine, 04050
        • Kyiv
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Dothan
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Mesa
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale
      • Tucson, Arizona, United States, 85704
        • Tucson
      • Tucson, Arizona, United States, 85712
        • Tucson
    • California
      • Canoga Park, California, United States, 91303
        • Canoga Park
      • Long Beach, California, United States, 90806
        • Long Beach
      • San Diego, California, United States, 92111
        • San Diego
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Greenwood Village
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Fort Myers
      • Loxahatchee Groves, Florida, United States, 33470
        • Loxahatchee
      • Miami, Florida, United States, 33126
        • Miami
      • Miami, Florida, United States, 33155
        • Miami
      • Orlando, Florida, United States, 32808
        • Orlando
      • Oviedo, Florida, United States, 32765
        • Oviedo
      • Plantation, Florida, United States, 33324
        • Plantation
      • Sarasota, Florida, United States, 34239
        • Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30363
        • Atlanta
      • Augusta, Georgia, United States, 30909
        • Augusta
      • Norcross, Georgia, United States, 30093
        • Norcross
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Oakbrook
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Shawnee
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • New Orleans
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas
    • New York
      • Port Jefferson, New York, United States, 11777
        • Port Jefferson
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Durham
      • Raleigh, North Carolina, United States, 27612
        • Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Winston Salem
    • Ohio
      • Englewood, Ohio, United States, 45322
        • Englewood
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis
      • Murfreesboro, Tennessee, United States, 37130
        • Murfreesboro
    • Texas
      • Austin, Texas, United States, 78705
        • Austin
      • Houston, Texas, United States, 77030
        • Houston
      • Webster, Texas, United States, 77598
        • Webster
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake City
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake City
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Norfolk
      • Richmond, Virginia, United States, 23235
        • Richmond
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Key Inclusion Criteria:

  1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
  2. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
  3. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy.

  4. During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days and

    1. Mean NMPP NRS score ≥ 2.5, or
    2. Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days.

Key Exclusion Criteria:

  1. Has a history of chronic pelvic pain that is not caused by endometriosis.
  2. Has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for ≥ 7 days per month.
  3. Has had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
  4. Has a history of or currently has osteoporosis or other metabolic bone disease.
  5. Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relugolix plus E2/NETA (Group A)
Relugolix co-administered with E2/NETA for 24 weeks.
Drug: Relugolix
Relugolix 40-mg tablet administered orally once daily.
Other Names:
  • TAK-385
  • MVT-601
Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
Other Names:
  • E2/NETA
Experimental: Relugolix plus Delayed E2/NETA (Group B)
Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Drug: Relugolix
Relugolix 40-mg tablet administered orally once daily.
Other Names:
  • TAK-385
  • MVT-601
Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
Other Names:
  • E2/NETA
Drug: Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
Placebo Comparator: Placebo (Group C)
Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Drug: Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
Drug: Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT)
Time Frame: Week 24 or EOT
Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Week 24 or EOT
Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT
Time Frame: Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Week 24 or EOT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24
Time Frame: Baseline, Week 24
Assessed using the Pain Domain of the EHP-30 questionnaire.
Baseline, Week 24
Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In NMPP NRS Score At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT
Time Frame: Week 24 or EOT
Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary.
Week 24 or EOT
Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24
Time Frame: Baseline to Week 24
Assessed using the pain domain of the EHP-30 questionnaire.
Baseline to Week 24
Dysmenorrhea Responder Rate By Month
Time Frame: Baseline to Week 24
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Baseline to Week 24
NMPP Responder Rate By Month
Time Frame: Baseline to Week 24
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Baseline to Week 24
Change In Dysmenorrhea NRS Score By Month
Time Frame: Baseline to Week 24
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline to Week 24
Change In NMPP NRS Score By Month
Time Frame: Baseline to Week 24
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline to Week 24
Change In Overall Pelvic Pain NRS Score By Month
Time Frame: Baseline to Week 24
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline to Week 24
Change In Dyspareunia NRS Score By Month
Time Frame: Baseline to Week 24
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Baseline to Week 24
Change From Baseline In Ibuprofen Use At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In Opioid Use At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT
Time Frame: Baseline, Week 24 or EOT
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
Baseline, Week 24 or EOT
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24
Time Frame: Baseline, Week 24
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Baseline, Week 24
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24
Time Frame: Week 24
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Week 24
Change From Baseline In PGA For NMPP Symptom Severity At Week 24
Time Frame: Baseline, Week 24
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Baseline, Week 24
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24
Time Frame: Week 24
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Week 24
Change From Baseline In PGA For Pain Severity At Week 24
Time Frame: Baseline, Week 24
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Baseline, Week 24
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24
Time Frame: Week 24
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Week 24
Change From Baseline In PGA For Function At Week 24
Time Frame: Baseline, Week 24
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Baseline, Week 24
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24
Time Frame: Week 24
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Week 24
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24
Time Frame: Week 24
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Week 24
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24
Time Frame: Week 24
The PGIC for NMPP is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Week 24
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24
Time Frame: Week 24
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse.
Week 24
Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24
Time Frame: Baseline, Week 24
Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire.
Baseline, Week 24
Change From Baseline In The EHP-30 Scale Total Score At Week 24
Time Frame: Baseline, Week 24
Assessed using the total score of the EHP-30 questionnaire.
Baseline, Week 24
Change From Baseline In The EHP Work Domain Score At Week 24
Time Frame: Baseline, Week 24
The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work.
Baseline, Week 24
Categorical Change From Baseline In Quality Of Life Assessed By European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Questionnaire At Week 24
Time Frame: Baseline, Week 24
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Baseline, Week 24
Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24
Time Frame: Baseline, Week 24
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Baseline, Week 24
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Time Frame: Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Week 24 or EOT
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Time Frame: Week 24 or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Week 24 or EOT
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA
Time Frame: Baseline, Week 24
Assessed using the Pain Domain of the EHP-30 questionnaire.
Baseline, Week 24
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24 For Relugolix Plus Delayed E2/NETA
Time Frame: Baseline to Week 24
Assessed using the pain domain of the EHP-30 questionnaire.
Baseline to Week 24
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12
Time Frame: Baseline, Week 12
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Baseline, Week 12
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24
Time Frame: Baseline, Week 24
Assessed by DXA scan.
Baseline, Week 24
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B
Time Frame: Week 12
Week 12
Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone
Time Frame: Baseline, Week 24
Blood samples will be collected from participants for hormonal measurements.
Baseline, Week 24
Pre-dose Relugolix Plasma Concentrations
Time Frame: Week 4
Blood samples will be collected from participants for relugolix measurements.
Week 4
Endometrial Biopsy At Week 24
Time Frame: Week 24
Primary diagnosis of endometrial biopsy assessment by pathologist.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myovant Sciences GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MVT-601-3101
  • 2017-001588-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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