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Trial record 2 of 2 for:    Relugolix LIBERTY

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

This study is currently recruiting participants.
Verified November 2017 by Myovant Sciences GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT03049735
First Posted: February 10, 2017
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Myovant Sciences GmbH
  Purpose
The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same population.

Condition Intervention Phase
Heavy Menstrual Bleeding Uterine Fibroid Drug: Relugolix Drug: Low-dose Hormonal Add-back Drug: Relugolix Placebo Drug: Low-dose Hormonal Add-back Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: LIBERTY 1: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy & Safety Study of Relugolix Co-Administered With/Without Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by Myovant Sciences GmbH:

Primary Outcome Measures:
  • Menstrual blood loss volume Group A vs Group C [ Time Frame: 24 weeks ]
    Proportion of women in the relugolix Group A versus the placebo Group C who achieve a menstrual blood loss volume of < 80 mL and a 50% reduction from baseline.


Secondary Outcome Measures:
  • Menstrual blood loss volume Group B vs Group C [ Time Frame: 24 weeks ]
    Proportion of women in the relugolix Group B versus the placebo Group C who achieve a menstrual blood loss volume of < 80 mL and a 50% reduction from baseline.


Estimated Enrollment: 390
Actual Study Start Date: January 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relugolix + Low-dose Hormonal Add-back Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Drug: Low-dose Hormonal Add-back
Estradiol and norethindrone acetate.
Experimental: Relugolix + Pbo - Relugolix + Add-back Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Drug: Low-dose Hormonal Add-back
Estradiol and norethindrone acetate.
Drug: Low-dose Hormonal Add-back Placebo
placebo capsule designed to match the over-encapsulated active low-dose hormonal add-back therapy in size, shape, color, and odor
Placebo Comparator: Placebo Drug: Relugolix Placebo
Placebo relugolix manufactured to match relugolix in size, shape, color, and odor
Drug: Low-dose Hormonal Add-back Placebo
placebo capsule designed to match the over-encapsulated active low-dose hormonal add-back therapy in size, shape, color, and odor

Detailed Description:

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose estradiol and norethindrone acetate (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose estradiol and norethindrone acetate (Group B) compared with 24 weeks of placebo (Group C).

Approximately 390 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled in the study and will participate for approximately 10 months. Participation will include an ~ 11 week screening period, 24 weeks of treatment and a follow up period of ~ 30 days. A diagnosis of uterine fibroids will be confirmed during the screening period by centrally-reviewed transvaginal and/or transabdominal ultrasound.

Following successful completion of the Screening period study participants will be randomized to Treatment Group A, B, or C and will attend visits monthly (ie, every 4 weeks). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.

All patients completing the Week 24 visit, including women randomized to placebo, will be offered the opportunity to enroll in an open-label extension study in which all eligible patients will receive relugolix co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll into the extension study will have a follow-up visit approximately 30 days after the end of treatment (ie, after the patient's last dose of study medication).

  Eligibility

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
Criteria

Inclusion Criteria:

  1. Is a premenopausal female aged 18 to 50 years old on the day of signing and dating the informed consent form;
  2. Has regularly-occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of one menstrual period until the start of the next, by patient history for at least 3 months prior to the Screening 1 visit;
  3. Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/or transabdominal ultrasound performed with saline or gel contrast during the screening period;
  4. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by a menstrual blood loss of ≥ 80 mL per cycle as measured by the alkaline hematin method during the screening period.

Exclusion Criteria:

  1. Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle;
  2. Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner;
  3. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the patient's bone mineral density is within normal limits;
  4. Has a history of the use of bisphosphonates, calcitonin/calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss;
  5. Has been a participant in an investigational drug or device study within the 1 month prior to Screening.
  Contacts and Locations
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): NCT03049735


Contacts
Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com

  Show 53 Study Locations
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences
  More Information

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03049735     History of Changes
Other Study ID Numbers: MVT-601-3001
First Submitted: February 8, 2017
First Posted: February 10, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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