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LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT03103087
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
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 or disease Intervention/treatment 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

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: LIBERTY 2: 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
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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
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 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 active low-dose hormonal add-back therapy in size, shape, color, and odor




Primary Outcome Measures :
  1. 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 :
  1. 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.



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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 DXA 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.

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): NCT03103087


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

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Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03103087     History of Changes
Other Study ID Numbers: MVT-601-3002
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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