Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03204331
Registration number
NCT03204331
Ethics application status
Date submitted
27/06/2017
Date registered
2/07/2017
Date last updated
28/06/2021
Titles & IDs
Public title
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Query!
Scientific title
SPIRIT 2: 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
Query!
Secondary ID [1]
0
0
2017-001632-19
Query!
Secondary ID [2]
0
0
MVT-601-3102
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Endometriosis Related Pain
0
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
0
0
0
0
Query!
Other reproductive health and childbirth disorders
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Menstruation and menopause
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Relugolix
Treatment: Drugs - Estradiol/norethindrone acetate
Treatment: Drugs - Estradiol/norethindrone acetate placebo
Treatment: Drugs - Relugolix placebo
Experimental: Relugolix plus E2/NETA (Group A) - Relugolix co-administered with E2/NETA for 24 weeks.
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.
Placebo Comparator: Placebo (Group C) - Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Treatment: Drugs: Relugolix
Relugolix 40-mg tablet administered orally once daily.
Treatment: Drugs: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
Treatment: Drugs: 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.
Treatment: Drugs: Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24 or EOT
Query!
Primary outcome [2]
0
0
Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 24 or EOT
Query!
Secondary outcome [1]
0
0
Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24
Query!
Assessment method [1]
0
0
Assessed using the Pain Domain of the EHP-30 questionnaire.
Query!
Timepoint [1]
0
0
Baseline, Week 24
Query!
Secondary outcome [2]
0
0
Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT
Query!
Assessment method [2]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [2]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [3]
0
0
Change From Baseline In NMPP NRS Score At Week 24 Or EOT
Query!
Assessment method [3]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [3]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [4]
0
0
Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT
Query!
Assessment method [4]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [4]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [5]
0
0
Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT
Query!
Assessment method [5]
0
0
Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary.
Query!
Timepoint [5]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [6]
0
0
Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT
Query!
Assessment method [6]
0
0
Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary.
Query!
Timepoint [6]
0
0
Week 24 or EOT
Query!
Secondary outcome [7]
0
0
Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT
Query!
Assessment method [7]
0
0
Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary.
Query!
Timepoint [7]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [8]
0
0
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24
Query!
Assessment method [8]
0
0
Assessed using the pain domain of the EHP-30 questionnaire.
Query!
Timepoint [8]
0
0
Baseline to Week 24
Query!
Secondary outcome [9]
0
0
Dysmenorrhea Responder Rate By Month
Query!
Assessment method [9]
0
0
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Query!
Timepoint [9]
0
0
Baseline to Week 24
Query!
Secondary outcome [10]
0
0
NMPP Responder Rate By Month
Query!
Assessment method [10]
0
0
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Query!
Timepoint [10]
0
0
Baseline to Week 24
Query!
Secondary outcome [11]
0
0
Change In Dysmenorrhea NRS Score By Month
Query!
Assessment method [11]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [11]
0
0
Baseline to Week 24
Query!
Secondary outcome [12]
0
0
Change In NMPP NRS Score By Month
Query!
Assessment method [12]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [12]
0
0
Baseline to Week 24
Query!
Secondary outcome [13]
0
0
Change In Overall Pelvic Pain NRS Score By Month
Query!
Assessment method [13]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [13]
0
0
Baseline to Week 24
Query!
Secondary outcome [14]
0
0
Change In Dyspareunia NRS Score By Month
Query!
Assessment method [14]
0
0
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Query!
Timepoint [14]
0
0
Baseline to Week 24
Query!
Secondary outcome [15]
0
0
Change From Baseline In Ibuprofen Use At Week 24 Or EOT
Query!
Assessment method [15]
0
0
Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Query!
Timepoint [15]
0
0
Baseline, Week 24
Query!
Secondary outcome [16]
0
0
Change From Baseline In Opioid Use At Week 24 Or EOT
Query!
Assessment method [16]
0
0
Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Query!
Timepoint [16]
0
0
Baseline, Week 24
Query!
Secondary outcome [17]
0
0
Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT
Query!
Assessment method [17]
0
0
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
Query!
Timepoint [17]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [18]
0
0
Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT
Query!
Assessment method [18]
0
0
Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
Query!
Timepoint [18]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [19]
0
0
Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT
Query!
Assessment method [19]
0
0
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
Query!
Timepoint [19]
0
0
Baseline, Week 24 or EOT
Query!
Secondary outcome [20]
0
0
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24
Query!
Assessment method [20]
0
0
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Query!
Timepoint [20]
0
0
Baseline, Week 24
Query!
Secondary outcome [21]
0
0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24
Query!
Assessment method [21]
0
0
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Query!
Timepoint [21]
0
0
Week 24
Query!
Secondary outcome [22]
0
0
Change From Baseline In PGA For NMPP Symptom Severity At Week 24
Query!
Assessment method [22]
0
0
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Query!
Timepoint [22]
0
0
Baseline, Week 24
Query!
Secondary outcome [23]
0
0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24
Query!
Assessment method [23]
0
0
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Query!
Timepoint [23]
0
0
Week 24
Query!
Secondary outcome [24]
0
0
Change From Baseline In PGA For Pain Severity At Week 24
Query!
Assessment method [24]
0
0
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Query!
Timepoint [24]
0
0
Baseline, Week 24
Query!
Secondary outcome [25]
0
0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24
Query!
Assessment method [25]
0
0
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Query!
Timepoint [25]
0
0
Week 24
Query!
Secondary outcome [26]
0
0
Change From Baseline In PGA For Function At Week 24
Query!
Assessment method [26]
0
0
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Query!
Timepoint [26]
0
0
Baseline, Week 24
Query!
Secondary outcome [27]
0
0
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24
Query!
Assessment method [27]
0
0
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Query!
Timepoint [27]
0
0
Week 24
Query!
Secondary outcome [28]
0
0
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
Week 24
Query!
Secondary outcome [29]
0
0
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Week 24
Query!
Secondary outcome [30]
0
0
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24
Query!
Assessment method [30]
0
0
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse.
Query!
Timepoint [30]
0
0
Week 24
Query!
Secondary outcome [31]
0
0
Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24
Query!
Assessment method [31]
0
0
Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire.
Query!
Timepoint [31]
0
0
Baseline, Week 24
Query!
Secondary outcome [32]
0
0
Change From Baseline In The EHP-30 Scale Total Score At Week 24
Query!
Assessment method [32]
0
0
Assessed using the total score of the EHP-30 questionnaire.
Query!
Timepoint [32]
0
0
Baseline, Week 24
Query!
Secondary outcome [33]
0
0
Change From Baseline In The EHP Work Domain Score At Week 24
Query!
Assessment method [33]
0
0
The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work.
Query!
Timepoint [33]
0
0
Baseline, Week 24
Query!
Secondary outcome [34]
0
0
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
Query!
Assessment method [34]
0
0
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Query!
Timepoint [34]
0
0
Baseline, Week 24
Query!
Secondary outcome [35]
0
0
Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24
Query!
Assessment method [35]
0
0
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Query!
Timepoint [35]
0
0
Baseline, Week 24
Query!
Secondary outcome [36]
0
0
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Week 24 or EOT
Query!
Secondary outcome [37]
0
0
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Week 24 or EOT
Query!
Secondary outcome [38]
0
0
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA
Query!
Assessment method [38]
0
0
Assessed using the Pain Domain of the EHP-30 questionnaire.
Query!
Timepoint [38]
0
0
Baseline, Week 24
Query!
Secondary outcome [39]
0
0
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
Query!
Assessment method [39]
0
0
Assessed using the pain domain of the EHP-30 questionnaire.
Query!
Timepoint [39]
0
0
Baseline to Week 24
Query!
Secondary outcome [40]
0
0
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12
Query!
Assessment method [40]
0
0
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Query!
Timepoint [40]
0
0
Baseline, Week 12
Query!
Secondary outcome [41]
0
0
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24
Query!
Assessment method [41]
0
0
Assessed by DXA scan.
Query!
Timepoint [41]
0
0
Baseline, Week 24
Query!
Secondary outcome [42]
0
0
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Week 12
Query!
Secondary outcome [43]
0
0
Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone
Query!
Assessment method [43]
0
0
Blood samples will be collected from participants for hormonal measurements.
Query!
Timepoint [43]
0
0
Baseline, Week 24
Query!
Eligibility
Key inclusion criteria
Key
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/05/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
623
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Sydney - Sydney
Query!
Recruitment hospital [2]
0
0
Wollongong - Wollongong
Query!
Recruitment hospital [3]
0
0
Sherwood - Sherwood
Query!
Recruitment hospital [4]
0
0
Adelaide - Adelaide
Query!
Recruitment hospital [5]
0
0
Nedlands - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2522 - Wollongong
Query!
Recruitment postcode(s) [3]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Mexico
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Tennessee
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Utah
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
RIO Grande DO SUL
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Rio Grande Do Sul
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
SAO Paulo
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Santiago
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Jihocesky KRAJ
Query!
Country [27]
0
0
Czechia
Query!
State/province [27]
0
0
Jihormoravsky KRAJ
Query!
Country [28]
0
0
Czechia
Query!
State/province [28]
0
0
Praha
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Ceské Budejovice
Query!
Country [30]
0
0
Georgia
Query!
State/province [30]
0
0
Borjomi
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Cagliari
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Catanzaro
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Napoli
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Pavia
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Roma
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Auckland
Query!
Country [37]
0
0
New Zealand
Query!
State/province [37]
0
0
Bay Of Plenty
Query!
Country [38]
0
0
New Zealand
Query!
State/province [38]
0
0
Manawatu-wanganui
Query!
Country [39]
0
0
New Zealand
Query!
State/province [39]
0
0
Christchurch
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Lodzkie
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Lubelskie
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Mazowieckie
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Podlaskie
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Slaskie
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Wielkopolskie
Query!
Country [46]
0
0
Romania
Query!
State/province [46]
0
0
Bucuresti
Query!
Country [47]
0
0
Romania
Query!
State/province [47]
0
0
Brasov
Query!
Country [48]
0
0
Sweden
Query!
State/province [48]
0
0
Skane
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Myovant Sciences GmbH
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03204331
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Myovant Medical Monitor
Query!
Address
0
0
Myovant Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03204331
Download to PDF