Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03654274
Other study ID # MVT-601-3103
Secondary ID 2017-004066-10
Status Completed
Phase Phase 3
First received
Last updated
Start date May 22, 2018
Est. completion date January 31, 2023

Study information

Verified date August 2023
Source Myovant Sciences GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible participants 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 participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2 (1.0 mg) and NETA (0.5 mg) for 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 E2/NETA. Baseline procedures for this extension study will be performed on the same day as the Week 24 Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be defined as the date of completion of the last Week 24 procedure in the parent study. Participants 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 participant 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.


Recruitment information / eligibility

Status Completed
Enrollment 802
Est. completion date January 31, 2023
Est. primary completion date December 16, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 51 Years
Eligibility Key Inclusion Criteria: 1. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102. 2. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame. 3. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these. Key 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. 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 a Z-score < -2.0 or has a = 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density. 4. Has any contraindication to treatment with low-dose E2 and NETA, including: 1. Known, suspected, or history of breast cancer; 2. Known or suspected estrogen-dependent neoplasia; 3. Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit; 4. History of or active arterial thromboembolic disease, including stroke and myocardial infarction; 5. Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA; 6. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden; 7. Migraine with aura; 8. History of porphyria. 5. Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102): 1. Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN); or 2. Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Argentina Ciudad de Buenos Aires Ciudad de Buenos Aires Buenos Aires
Argentina Cordoba Cordoba
Argentina Rosario Rosario Santa Fe
Argentina San Isidro San Isidro Buenos Aires
Australia Adelaide Adelaide South Australia
Australia Nedlands Nedlands Western Australia
Australia Sydney Sydney New South Wales
Australia Taringa Taringa Queensland
Australia Wollongong Wollongong NS
Belgium Brussels Brussels
Belgium Gent Gent Oost-vlaanderen
Belgium La Louvière La Louvière Hainaut
Belgium Leuven Leuven Flemish Brabant
Brazil Passo Fundo Passo Fundo Rio Grande Do Sul
Brazil Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Porto Alegre Porto Alegre Sao Paulo
Brazil São Bernardo do Campo São Bernardo do Campo Sao Paulo
Brazil Sao Paulo Sao Paulo
Brazil Sao Paulo São Paulo Sao Paulo
Brazil São Paulo São Paulo Sao Paulo
Brazil São Paulo São Paulo Sao Paulo
Bulgaria Blagoevgrad Blagoevgrad
Bulgaria Pleven Pleven
Bulgaria Sofia Sofia Sofiya
Bulgaria Sofia Sofia Sofiya
Bulgaria Sofia Sofia Sofiya
Bulgaria Sofia Sofia Sofiya
Bulgaria Stara Zagora Stara Zagora
Bulgaria Varna Varna
Canada Red Deer Red Deer Alberta
Canada Victoriaville Victoriaville Quebec
Canada Waterloo Waterloo Ontario
Chile Santiago Santiago
Chile Santiago Santiago
Chile Santiago Santiago
Czechia Ceské Budejovice Ceské Budejovice
Czechia Náchod Náchod Kralovehradecky
Czechia Olomouc Olomouc
Czechia Písek Písek Jihocesky Kraj
Czechia Praha 10 Praha 10 Praha
Czechia Praha 2 Praha 2 Praha
Czechia Praha 8 - Liben Praha 8 - Liben
Czechia Tábor Tábor Jihormoravsky Kraj
Czechia Vodnany Vodnany Jihocesky
Finland Helsinki Helsinki Southern Finland
Finland Kuopio Kuopio Eastern Finland
Finland Oulu Oulu
Georgia Tbilisi Tbilisi
Hungary Békéscsaba Békéscsaba Bekes
Hungary Debrecen Debrecen Hajdu-bihar
Hungary Debrecen Debrecen Hajdu-bihar
Hungary Debrecen Debrecen Hajdu-bihar
Hungary Gyula Gyula Bekes
Hungary Kecskemét Kecskemét Bacs-kiskun
Hungary Nyíregyháza Nyíregyháza Szabolcs-szatmar-bereg
Hungary Pécs Pécs Baranya
Hungary Szeged Szeged Csongrad
Italy Catanzaro Catanzaro
Italy Monserrato Monserrato Cagliari
Italy Napoli Napoli
Italy Pavia Pavia
Italy Roma Roma
New Zealand Christchurch Christchurch
New Zealand Palmerston North Palmerston North Manawatu-wanganui
New Zealand Remuera Remuera Auckland
Poland Bialystok Bialystok Podlaskie
Poland Katowice Katowice Slaskie
Poland Katowice Katowice Slaskie
Poland Lódz Lódz Lodzkie
Poland Lublin Lublin Lubelskie
Poland Lublin Lublin Lubelskie
Poland Lublin Lublin Lubelskie
Poland Lublin Lublin Lubelskie
Poland Skórzewo Skórzewo Wielkopolskie
Poland Szczecin Szczecin Zachodniopomorskie
Poland Warszawa Warszawa Mazowieckie
Poland Warszawa Warszawa Mazowieckie
Poland Warszawa Warszawa Mazowieckie
Portugal Almada Almada Lisboa
Portugal Coimbra Coimbra
Portugal Covilhã Covilhã
Portugal Porto Porto
Romania Brasov Brasov
Romania Bucure?ti Bucure?ti
Romania Bucuresti Bucuresti
Romania Bucuresti Bucuresti
Romania Bucuresti Bucuresti
South Africa Cape Town Cape Town Western Cape
South Africa Centurion Centurion Gauteng
South Africa Durban Durban Kwazulu-natal
South Africa Port Elizabeth Port Elizabeth Eastern Cape
South Africa Roodepoort Roodepoort Gauteng
Spain Madrid Madrid
Spain Valencia Valencia
Ukraine Chernivtsi Chernivtsi
Ukraine Ivano-Frankivsk Ivano-Frankivsk
Ukraine Kharkiv Kharkiv
Ukraine Kiev Kiev
Ukraine Kiev Kiev
Ukraine Kyiv Kyiv
Ukraine Kyiv Kyiv Kiev City
Ukraine Kyiv Kyiv Kiev City
Ukraine Kyiv Kyiv Kiev
Ukraine Zaporizhzhya Zaporizhzhya
Ukraine Zaporizhzhya Zaporizhzhya
Ukraine Zaporizhzhya Zaporizhzhya
Ukraine Zaporizhzhya Zaporizhzhya
United States Akron Akron Ohio
United States Andalusia Andalusia Alabama
United States Atlanta Atlanta Georgia
United States Atlanta Atlanta Georgia
United States Augusta Augusta Georgia
United States Aventura Aventura Florida
United States Beaumont Beaumont Texas
United States Canoga Park Canoga Park California
United States Chattanooga Chattanooga Tennessee
United States Columbia Columbia South Carolina
United States Columbus Columbus Ohio
United States Corpus Christi Corpus Christi Texas
United States Dallas Dallas Texas
United States Durham Durham North Carolina
United States Englewood Englewood Ohio
United States Fort Myers Fort Myers Florida
United States Fort Worth Fort Worth Texas
United States Greenwood Village Greenwood Village Colorado
United States Hershey Hershey Pennsylvania
United States Hialeah Hialeah Florida
United States Hialeah Hialeah Florida
United States Houston Houston Texas
United States Houston Houston Texas
United States Idaho Falls Idaho Falls Idaho
United States Irving Irving Texas
United States Jefferson City Jefferson City Missouri
United States Las Vegas Las Vegas Nevada
United States Los Angeles Los Angeles California
United States Margate Margate Florida
United States Marrero Marrero Louisiana
United States Memphis Memphis Tennessee
United States Miami Miami Florida
United States Miami Miami Florida
United States New Bern New Bern North Carolina
United States Norcross Norcross Georgia
United States Norfolk Norfolk Virginia
United States Oakbrook Oakbrook Terrace Illinois
United States Omaha Omaha Nebraska
United States Park Ridge Park Ridge Illinois
United States Richmond Richmond Virginia
United States Saginaw Saginaw Michigan
United States St. Louis Saint Louis Missouri
United States Salt Lake City Salt Lake City Utah
United States Salt Lake City Salt Lake City Utah
United States Salt Lake City Salt Lake City Utah
United States San Antonio San Antonio Texas
United States San Diego San Diego California
United States Sarasota Sarasota Florida
United States Scottsdale Scottsdale Arizona
United States Seattle Seattle Washington
United States Shawnee Shawnee Mission Kansas
United States Sugar Land Sugar Land Texas
United States Tampa Tampa Florida
United States Towson Towson Maryland
United States Tucson Tucson Arizona
United States Tuscon Tucson Arizona
United States Virginia Beach Virginia Beach Virginia
United States Washington Washington District of Columbia
United States Webster Webster Texas
United States Winston Salem Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Myovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Finland,  Georgia,  Hungary,  Italy,  New Zealand,  Poland,  Portugal,  Romania,  South Africa,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Week 52
Primary Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Week 52
Primary Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Week 104
Primary Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52 Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. Week 52
Secondary Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104 Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 Assessed based on usage of study-specified opioids for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified opioids for treatment of endometriosis-associated pain as needed for pain but not prophylactically. Week 104
Secondary Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 Assessed based on usage of study-specified analgesics for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified analgesics for treatment of endometriosis-associated pain as needed for pain but not prophylactically. Week 104
Secondary Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52 The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52 The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52 The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104 The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). Week 52
Secondary Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). Week 52
Secondary Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit. Week 52
Secondary Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit. Week 104
Secondary Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of =3% at the lumbar spine and/or total hip compared with the parent study baseline. Week 52
Secondary Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of =3% at the lumbar spine and/or total hip compared with the parent study baseline. Week 104
Secondary Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit. Week 52
Secondary Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit. Week 104
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4