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Trial record 11 of 113 for:    centurion

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

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ClinicalTrials.gov Identifier: NCT03654274
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Relugolix Drug: Estradiol/norethindrone acetate Phase 3

Detailed Description:

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3101 (SPIRIT 1 - NCT03204318) or MVT-601-3102 (SPIRIT 2 - NCT03204331). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 80 weeks.

Approximately 800 women with endometriosis-associated pain will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 104 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.

Screening and baseline procedures will be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3103 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 80 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 31, 2022


Arm Intervention/treatment
Experimental: Relugolix plus estradiol/norethindrone acetate
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.
Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Other Name: TAK-385

Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Other Names:
  • E2/NETA
  • low-dose hormonal add-back




Primary Outcome Measures :
  1. Proportion of women who respond or maintain a response based on daily assessment of dysmenorrhea [ Time Frame: 52 and 104 weeks ]
    Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary.

  2. Proportion of women who respond or maintain a response based on daily assessment of nonmenstrual pelvic pain [ Time Frame: 52 and 104 weeks ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.


Secondary Outcome Measures :
  1. Change in function due to endometriosis associated pain [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using the Pain Domain of the Endometriosis Health Profile (EHP)-30 questionnaire.

  2. Change in dysmenorrhea NRS scores [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.

  3. Change in nonmenstrual pelvic pain NRS scores [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.

  4. Change in dyspareunia NRS scores [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.

  5. Proportion of patients who are better or much better on the Patient Global Impression of Change (PGIC) for dysmenorrhea [ Time Frame: from parent study Baseline up to Week 52 ]
    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.

  6. Proportion of patients who are better or much better on the PGIC for nonmenstrual pelvic pain [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGIC for nonmenstrual pelvic pain is a 1-item questionnaire designed to assess participants impression of change in the severity of pain when they are not menstruating.

  7. Proportion of patients who are better or much better on PGIC for dyspareunia [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants impression of change in the severity of their pain during sexual intercourse.

  8. Change in the mean dysmenorrhea functional impairment [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary.

  9. Change in the mean nonmenstrual pelvic pain functional impairment [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary.

  10. Change in the mean dyspareunia functional impairment [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary.

  11. Change in Patient Global Assessment (PGA) for function [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    The PGA for function is a 1-item questionnaire designed to assess participants impression of how their pain affected their usual activities.

  12. Change in PGA for pain [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    The PGA for function is a 1-item questionnaire designed to assess participants impression of the severity of their pain.

  13. Proportion of responders based on their EHP-30 Pain Domain score [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using the Pain Domain of the EHP-30 questionnaire.

  14. Change in each of the non-pain EHP-30 domains (Control and Powerlessness, Social Support, Emotional Well-being, and Self-Image) [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed using EHP-30 questionnaire.

  15. Bone Mineral Density [ Time Frame: from parent study Baseline at Week 52 and Week 104 ]
    Assessed by dual-energy X-ray absorptiometry scan.

  16. The number and percentage of participants with adverse events (AEs) as a measure of safety and tolerability [ Time Frame: 52 weeks and 104 weeks ]
    Assessed frequency and severity of AEs and serious AEs.

  17. Serum concentrations of estradiol [ Time Frame: 52 weeks and 104 weeks ]
    Blood samples will be collected from participants for estradiol measurements.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either MVT-601-3101 or MVT-601-3102.

Exclusion Criteria:

  1. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
  2. Met a withdrawal criterion in the parent study (MVT-601-3101 or MVT-601-3102).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654274


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Locations
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United States, Alabama
Andalusia
Andalusia, Alabama, United States, 36420
United States, Arizona
Scottsdale
Scottsdale, Arizona, United States, 85251
Tucson
Tucson, Arizona, United States, 85704
Tuscon
Tucson, Arizona, United States, 85712
United States, California
San Diego
San Diego, California, United States, 92111
United States, Colorado
Greenwood Village
Greenwood Village, Colorado, United States, 80111
United States, Florida
Aventura
Aventura, Florida, United States, 33180
Hialeah
Hialeah, Florida, United States, 33012
Hialeah
Hialeah, Florida, United States, 33016
Margate
Margate, Florida, United States, 33063
Miami
Miami, Florida, United States, 33126
Orlando
Orlando, Florida, United States, 32808
Tampa
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta
Atlanta, Georgia, United States, 30312
Atlanta
Atlanta, Georgia, United States, 30363
United States, Idaho
Idaho Falls
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Oakbrook
Oakbrook Terrace, Illinois, United States, 60523
United States, Louisiana
Marrero
Marrero, Louisiana, United States, 70072
United States, Maryland
Towson
Towson, Maryland, United States, 21204
United States, Missouri
Jefferson City
Jefferson City, Missouri, United States, 65109
St. Louis
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Omaha
Omaha, Nebraska, United States, 68124
United States, Nevada
Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New York
Port Jefferson
Port Jefferson, New York, United States, 11777
United States, North Carolina
New Bern
New Bern, North Carolina, United States, 28562
Raleigh
Raleigh, North Carolina, United States, 27612
Winston Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Akron
Akron, Ohio, United States, 44313
Columbus
Columbus, Ohio, United States, 43235
Englewood
Englewood, Ohio, United States, 45322
United States, Pennsylvania
Hershey
Hershey, Pennsylvania, United States, 17033-0850
United States, Tennessee
Chattanooga
Chattanooga, Tennessee, United States, 37404
Memphis
Memphis, Tennessee, United States, 38120
United States, Texas
Beaumont
Beaumont, Texas, United States, 77702
Fort Worth
Fort Worth, Texas, United States, 76104
Houston
Houston, Texas, United States, 77054
San Antonio
San Antonio, Texas, United States, 78258
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Salt Lake City
Salt Lake City, Utah, United States, 84107
Salt Lake City
Salt Lake City, Utah, United States, 84124
United States, Virginia
Norfolk
Norfolk, Virginia, United States, 23507
Virginia Beach
Virginia Beach, Virginia, United States, 23456
Argentina
Ciudad de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1128AAF
San Isidro
San Isidro, Buenos Aires, Argentina, B1642CKL
Australia, New South Wales
Sydney
Sydney, New South Wales, Australia, 2000
Australia, Queensland
Sherwood
Sherwood, Queensland, Australia, 4075
Belgium
Leuven
Leuven, Flemish Brabant, Belgium, 3000
La Louvière
La Louvière, Hainaut, Belgium, 7100
Gent
Gent, Oost-vlaanderen, Belgium, 9000
Brussels
Brussels, Belgium, 1070
Brazil
Passo Fundo
Passo Fundo, RIO Grande DO SUL, Brazil, 99010-080
Bulgaria
Sofia
Sofia, Sofiya, Bulgaria, 1233
Sofia
Sofia, Sofiya, Bulgaria, 1431
Sofia
Sofia, Sofiya, Bulgaria, 1504
Blagoevgrad
Blagoevgrad, Bulgaria, 2700
Pleven
Pleven, Bulgaria, 5809
Stara Zagora
Stara Zagora, Bulgaria, 6003
Varna
Varna, Bulgaria, 9005
Canada, Alberta
Red Deer
Red Deer, Alberta, Canada, T4N 6V7
Canada, Quebec
Victoriaville
Victoriaville, Quebec, Canada, G6P 6P6
Chile
Santiago
Santiago, Chile, 8360160
Czechia
Písek
Písek, Jihocesky KRAJ, Czechia, 39701
Tábor
Tábor, Jihormoravsky KRAJ, Czechia, 390 03
Náchod
Náchod, Czechia, 547 01
Olomouc
Olomouc, Czechia, 772 00
Praha 8 - Libeň
Praha 8 - Libeň, Czechia, 180 81
Vodňany
Vodňany, Czechia, 389 01
Vysoké Mýto
Vysoké Mýto, Czechia, 566 01
České Budějovice
České Budějovice, Czechia, 370 01
Finland
Kuopio
Kuopio, Eastern Finland, Finland, FI-70110
Georgia
Tbilisi
Tbilisi, Georgia, 0159
Hungary
Kecskemét
Kecskemét, Bacs-kiskun, Hungary, 6000
Békéscsaba
Békéscsaba, Bekes, Hungary, 5600
Gyula
Gyula, Bekes, Hungary, 5700
Szeged
Szeged, Csongrad, Hungary, 6725
Debrecen
Debrecen, Hajdu-bihar, Hungary, 4024
Debrecen
Debrecen, Hajdu-bihar, Hungary, 4032
Italy
Catanzaro
Catanzaro, Italy, 88100
Roma
Roma, Italy, 00168
New Zealand
Remuera
Remuera, Auckland, New Zealand, 1050
Tauranga
Tauranga, BAY OF Plenty, New Zealand, 3112
Palmerston North
Palmerston North, Manawatu-wanganui, New Zealand, 4442
Christchurch
Christchurch, New Zealand, 8013
Poland
Łódź
Łódź, Lodzkie, Poland, 90-602
Lublin
Lublin, Lubelskie, Poland, 20-064
Lublin
Lublin, Lubelskie, Poland, 20-093
Lublin
Lublin, Lubelskie, Poland, 20-632
Lublin
Lublin, Lubelskie, Poland, 20-880
Kraków
Kraków, Malopolskie, Poland, 31-121
Warszawa
Warszawa, Mazowieckie, Poland, 02-201
Warszawa
Warszawa, Mazowieckie, Poland, 02-929
Katowice
Katowice, Slaskie, Poland, 40-081
Katowice
Katowice, Slaskie, Poland, 40-301
Poznań
Poznań, Wielkopolskie, Poland, 60-192
Szczecin
Szczecin, Zachodniopomorskie, Poland, 71-434
Romania
Bucuresti
Bucuresti, Romania, 012071
Bucuresti
Bucuresti, Romania, 022441
South Africa
Port Elizabeth
Port Elizabeth, Eastern CAPE, South Africa, 6001
Centurion
Centurion, Gauteng, South Africa, 0157
Roodepoort
Roodepoort, Gauteng, South Africa, 1724
Durban
Durban, Kwazulu-natal, South Africa, 4126
Sweden
Stockholm
Stockholm, Sweden, 14186
Sponsors and Collaborators
Myovant Sciences GmbH

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Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03654274     History of Changes
Other Study ID Numbers: MVT-601-3103
2017-004066-10 ( EudraCT Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myovant Sciences GmbH:
Endometriosis
Dysmenorrhea
Pain
Dypareunia

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone Acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral