Trial record 1 of 3 for:    Relugolix LIBERTY
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LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03412890
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2018
Last Update Posted : January 31, 2018
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Uterine Fibroid Drug: Relugolix Drug: Low-Dose Hormonal Add-Back 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-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). 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 28 weeks.

Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids 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 52 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-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label Extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Relugolix + Low-Dose Hormonal Add-Back Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Drug: Low-Dose Hormonal Add-Back
Over-encapsulated estradiol 1.0 mg and norethindrone acetate 0.5 mg co-formulated tablet, co-administered with relugolix once daily

Primary Outcome Measures :
  1. Menstrual Blood Loss Volume [ Time Frame: 52 Weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either MVT‑601‑3001 or MVT‑601‑3002

Key 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. Met a withdrawal criterion in the parent study (MVT‑601‑3001 or MVT‑601‑3002).

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 identifier (NCT number): NCT03412890

United States, Arizona
Mesa, Arizona, United States, 85209
United States, Colorado
Denver, Colorado, United States, 80209
United States, Florida
Margate, Florida, United States, 33063
United States, Louisiana
Metairie, Louisiana, United States, 70001
United States, Nevada
Las Vegas
Las Vegas, Nevada, United States, 89128
United States, Ohio
Englewood, Ohio, United States, 45322
United States, Texas
Houston, Texas, United States, 77054
Sponsors and Collaborators
Myovant Sciences GmbH
Study Director: Myovant Medical Monitor, MD Myovant Sciences

Responsible Party: Myovant Sciences GmbH Identifier: NCT03412890     History of Changes
Other Study ID Numbers: MVT-601-3003
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Norethindrone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents