A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroids

LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003310-74-BE

Enrollment

600

Registered

2017-12-15

Start date

2018-03-15

Completion date

Unknown

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heavy menstrual bleeding associated with uterine fibroids MedDRA version: 20.0 Level: LLT Classification code 10027331 Term: Menstrual flow altered System Organ Class: 100000004872 MedDRA version: 21.1 Level: LLT Classification code 10046783 Term: Uterine fibroid System Organ Class: 100000004864

Interventions

Product Name: Relugolix Product Code: TAK-385, RVT-601, MVT-601 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Relugolix CAS Number: 737789-87-6 Current Sponsor code: MVT-601 Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Completed 24 weeks of study drug treatment and study participation in either MVT-601-3001 orMVT-601-3002; 2.Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures for MVT-601-3003; 3.Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids withinthe study period, including during the Safety Follow-Up period; 4.Has a negative urine pregnancy test at the Week 24/Baseline visit; 5.Agrees to continue to use acceptable nonhormonal contraceptive methods as described in Section 4.6 consistently during the Open-Label Treatment period and for at least 30 days after the last dose of study drug. However, the patient is not required to use the specified nonhormonalcontraceptive methods if she: a.Has a sexual partner(s) who was vasectomized at least 6 months prior to the Week 24/Baseline visit; b.Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the Week 24/Baseline visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram) and there must be no evidence ofpost-Essure syndrome; c.Has a nonhormonal intrauterine device (eg, Paragard®) placed in the uterus; d.Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above; e.Practices total abstinence from sexual intercourse, as her preferred lifestyle; periodic abstinence is not acceptable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVT-601-3001 or MVT-601-3002); 2.Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur (eg, bilateral hip replacement, spinal hardware in the lumbar spine); 3.Has a Z-score 2.0 times the upper limit of normal (ULN); or b.Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome); 9.Is currently pregnant or lactating, or intends to become pregnant during the study period or within1 month after the last dose of study drug, or plans to donate ova during the study period or within2 months after the last dose of study drug; 10.Has a decline in presenting visual acuity score as defined below (unless explained by refractive error or approved by the Sponsor): a.90 or lower and 5 or more points lower at Week 24/Baseline visit relative to the parent study Baseline visit; OR b.The presenting visual acuity score has decreased by 10 or more points at the Week 24/Baseline visit relative to the parent study Baseline visit; Note: visual acuity score must have been obtained with corrective lenses, if applicable; 11. Is inappropriate for participation in this study because of conditions that may interfere with interpretation of study results or prevent the patient from complying with study requirements, as determined by the investigator, sub-investigator, or medical monitor. 12. Met a withdrawal criterion in the parent study (MVT-601-3001 or MVT-601-3002).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on heavy menstrual bleeding associated with uterine fibroids.;Secondary Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on the following: o Achievement/maintenance of amenorrhea; o Hemoglobin; o Changes in symptom severity and quality of life related to uterine fibroids as measured by the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL); o Impact of heavy menstrual bleeding on social, leisure, and physical activities as measured by the Menorrhagia Impact Questionnaire (MIQ); o Uterine volume; o Uterine fibroid volume.;Primary end point(s): •Proportion of women who achieve or maintain a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline to the last 35 days of treatment, as measured by the alkaline hematin method.;Timepoint(s) of evaluation of this end point: from parent study Baseline to the last 35 days of treatment	—

Measure

Time frame

Main Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on heavy menstrual bleeding associated with uterine fibroids.;Secondary Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on the following: o Achievement/maintenance of amenorrhea; o Hemoglobin; o Changes in symptom severity and quality of life related to uterine fibroids as measured by the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL); o Impact of heavy menstrual bleeding on social, leisure, and physical activities as measured by the Menorrhagia Impact Questionnaire (MIQ); o Uterine volume; o Uterine fibroid volume.;Primary end point(s): •Proportion of women who achieve or maintain a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline to the last 35 days of treatment, as measured by the alkaline hematin method.;Timepoint(s) of evaluation of this end point: from parent study Baseline to the last 35 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): •Time to achieve a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline menstrual blood loss volume as measured by the alkaline hematin method; •Change from parent study Baseline to Week 52 in menstrual blood loss; •Proportion of women who achieve or maintain amenorrhea over the last 35 days of treatment; •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve an increase of = 1 g/dL from parent study Baseline at Week 52; •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve a normal hemoglobin at Week 52; •Change from parent study Baseline to Week 52 in hemoglobin; •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Symptom Severity; •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Health-related Quality of Life subscales and total score; •Change from parent study Baseline to Week 52 in the MIQ score for physical activities; •Change from parent study Baseline to Week 52 in the MIQ score for social and leisure activities; •Change from parent study Baseline to Week 52 in uterine volume; •Change from parent study Baseline to Week 52 in uterine fibroid volume. ;Timepoint(s) of evaluation of this end point: from parent study Baseline to Week 52	—

Measure

Time frame

Secondary end point(s): •Time to achieve a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline menstrual blood loss volume as measured by the alkaline hematin method; •Change from parent study Baseline to Week 52 in menstrual blood loss; •Proportion of women who achieve or maintain amenorrhea over the last 35 days of treatment; •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve an increase of = 1 g/dL from parent study Baseline at Week 52; •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve a normal hemoglobin at Week 52; •Change from parent study Baseline to Week 52 in hemoglobin; •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Symptom Severity; •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Health-related Quality of Life subscales and total score; •Change from parent study Baseline to Week 52 in the MIQ score for physical activities; •Change from parent study Baseline to Week 52 in the MIQ score for social and leisure activities; •Change from parent study Baseline to Week 52 in uterine volume; •Change from parent study Baseline to Week 52 in uterine fibroid volume. ;Timepoint(s) of evaluation of this end point: from parent study Baseline to Week 52

—

Countries

Belgium, Brazil, Chile, Czechia, Czech Republic, Hungary, Italy, Poland, South Africa, United Kingdom, United States

Contacts

Public ContactClinical Trials at Myovant

Myovant Sciences GmbH

ClinicalTrials@myovant.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026