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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX


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All Clinical Trials for Estradiol; Norethindrone Acetate; Relugolix

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03049735 ↗ LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-04-26 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03103087 ↗ LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-06-14 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03204318 ↗ SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Completed Myovant Sciences GmbH Phase 3 2017-12-07 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estradiol; Norethindrone Acetate; Relugolix

Condition Name

Condition Name for Estradiol; Norethindrone Acetate; Relugolix
Intervention Trials
Uterine Fibroid 3
Heavy Menstrual Bleeding 3
Uterine Fibroids 2
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Condition MeSH

Condition MeSH for Estradiol; Norethindrone Acetate; Relugolix
Intervention Trials
Leiomyoma 7
Myofibroma 6
Menorrhagia 5
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Clinical Trial Locations for Estradiol; Norethindrone Acetate; Relugolix

Trials by Country

Trials by Country for Estradiol; Norethindrone Acetate; Relugolix
Location Trials
United States 193
Poland 37
Hungary 23
South Africa 18
Czechia 15
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Trials by US State

Trials by US State for Estradiol; Norethindrone Acetate; Relugolix
Location Trials
Florida 9
Louisiana 8
Illinois 8
Georgia 8
Alabama 8
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Clinical Trial Progress for Estradiol; Norethindrone Acetate; Relugolix

Clinical Trial Phase

Clinical Trial Phase for Estradiol; Norethindrone Acetate; Relugolix
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Estradiol; Norethindrone Acetate; Relugolix
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 2
Not yet recruiting 2
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Clinical Trial Sponsors for Estradiol; Norethindrone Acetate; Relugolix

Sponsor Name

Sponsor Name for Estradiol; Norethindrone Acetate; Relugolix
Sponsor Trials
Myovant Sciences GmbH 12
University of Chicago 1
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Sponsor Type

Sponsor Type for Estradiol; Norethindrone Acetate; Relugolix
Sponsor Trials
Industry 12
Other 1
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Clinical Trials, Market Analysis, and Projections for Estradiol, Norethindrone Acetate, and Relugolix (MYFEMBREE)

Introduction

MYFEMBREE, a fixed-dose combination of estradiol, norethindrone acetate, and relugolix, has been making significant strides in the treatment of various gynecological conditions. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

LIBERTY Trials for Uterine Fibroids

The efficacy of MYFEMBREE in treating heavy menstrual bleeding (HMB) associated with uterine fibroids was evaluated in two identical, international, randomized, double-blind, placebo-controlled phase 3 trials, LIBERTY-1 and LIBERTY-2. These trials involved a total of 770 patients, with 79% completing the treatment. The primary efficacy endpoint was the reduction in menstrual blood loss, defined as a volume of less than 80 ml and a reduction of at least 50% from baseline over the last 35 days of the 24-week treatment period. Significantly more patients in the MYFEMBREE group achieved this response compared to the placebo group, with improvements seen as early as week 4 and sustained throughout the study period[1][5].

SPIRIT Trials for Endometriosis

For the treatment of moderate to severe pain associated with endometriosis, MYFEMBREE was evaluated in the SPIRIT-1 and SPIRIT-2 trials. These trials enrolled 1261 women and included a 30-day placebo run-in period followed by randomization to either MYFEMBREE, placebo, or relugolix monotherapy for 12 weeks followed by MYFEMBREE for 12 weeks. The co-primary efficacy endpoints were based on the Dysmenorrhea Numerical Rating Scale (DYS NRS) and Nonmenstrual Pelvic Pain (NMPP) NRS scores at week 24. The results showed significant improvements in pain scores for the MYFEMBREE group compared to the placebo group[1][4].

Mechanism of Action

MYFEMBREE works through a multi-faceted mechanism:

  • Relugolix: Acts as a non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, reducing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which in turn reduces estrogen and progesterone production. This reduction helps in decreasing menstrual bleeding associated with uterine fibroids and pain associated with endometriosis[1][3][5].
  • Estradiol: Mitigates the risk of bone mineral density loss and vasomotor symptoms induced by the hypoestrogenic state caused by relugolix[1][3].
  • Norethindrone Acetate: Enhances cellular differentiation and opposes the proliferative actions of estrogens, further stabilizing the hormonal balance[1][3].

Safety Considerations

The safety profile of MYFEMBREE includes several key considerations:

  • Bone Mineral Density (BMD) Loss: Treatment with MYFEMBREE should be limited to 24 months due to the risk of BMD loss that may not be reversible[1].
  • Thromboembolic Disorders and Vascular Events: A boxed warning is in place for these risks, which are common with estrogen and progestin combinations[1].
  • Mood Disorders: Hot flushes, depression, and other mood disorders have been reported due to the suppression of estrogen and progesterone[1].

Market Analysis

Current Indications and Market Position

MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine fibroids and the treatment of moderate to severe pain associated with endometriosis. Given its efficacy in clinical trials, MYFEMBREE has positioned itself as a significant player in the gynecological treatment market. The drug's unique combination of a GnRH antagonist with estrogen and progestin addresses multiple symptoms effectively, making it a preferred choice for many healthcare providers[1][2][5].

Likelihood of Approval and Phase Transition Success Rate

GlobalData's proprietary machine learning models predict a high likelihood of approval for MYFEMBREE in additional indications, such as female contraception and further expansion in endometriosis treatment. These models consider historical data and real-time events impacting the clinical development process and regulatory considerations[2].

Competitive Landscape

The market for treatments of uterine fibroids and endometriosis is competitive, with various hormonal and non-hormonal therapies available. However, MYFEMBREE's unique mechanism of action and comprehensive efficacy profile set it apart. The drug's ability to manage both menstrual bleeding and pain associated with these conditions makes it a valuable option for patients and healthcare providers[1][2].

Future Projections

Expansion of Indications

MYFEMBREE is under development for additional indications, including female contraception and further applications in endometriosis. The success in current indications and the ongoing clinical trials suggest a strong potential for expansion, which could significantly increase its market share and patient base[2].

Long-Term Efficacy and Safety

Long-term extension studies have shown that the efficacy of MYFEMBREE is sustained over 52 weeks and even up to 104 weeks in some cases. This long-term data is crucial for establishing the drug's safety and efficacy profile over extended treatment periods, which will be vital for its continued market success[1].

Regulatory and Market Trends

Regulatory approvals and market trends are expected to continue favoring MYFEMBREE. The drug's innovative approach to treating gynecological conditions aligns with current healthcare trends towards more targeted and effective therapies. As more data becomes available, MYFEMBREE is likely to become a standard treatment option in its indicated areas[1][2].

Key Takeaways

  • Efficacy in Clinical Trials: MYFEMBREE has demonstrated significant efficacy in reducing menstrual blood loss and pain associated with uterine fibroids and endometriosis.
  • Unique Mechanism of Action: The combination of relugolix, estradiol, and norethindrone acetate provides a comprehensive approach to managing hormonal imbalances.
  • Safety Considerations: While effective, MYFEMBREE carries risks such as BMD loss and thromboembolic disorders, necessitating careful patient selection and monitoring.
  • Market Position: MYFEMBREE is well-positioned in the market due to its efficacy and unique mechanism, with potential for expansion into additional indications.
  • Future Projections: Long-term efficacy and safety data, along with regulatory trends, suggest a bright future for MYFEMBREE in the treatment of gynecological conditions.

FAQs

Q: What are the primary indications for MYFEMBREE?

A: MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine fibroids and the treatment of moderate to severe pain associated with endometriosis.

Q: How does MYFEMBREE work?

A: MYFEMBREE works through a combination of relugolix (a GnRH antagonist), estradiol, and norethindrone acetate, which together reduce estrogen and progesterone production, mitigate bone mineral density loss, and stabilize hormonal balance.

Q: What are the key safety considerations for MYFEMBREE?

A: Key safety considerations include the risk of bone mineral density loss, thromboembolic disorders, and vascular events, as well as mood disorders such as hot flushes and depression.

Q: What is the current market position of MYFEMBREE?

A: MYFEMBREE is a significant player in the gynecological treatment market due to its efficacy in clinical trials and its unique mechanism of action.

Q: What are the future projections for MYFEMBREE?

A: Future projections include potential expansion into additional indications such as female contraception, sustained long-term efficacy and safety, and continued regulatory and market favorability.

Sources

  1. National Drug Monograph: Relugolix, Estradiol, Norethindrone (MYFEMBREE) National Drug Monograph Clinical Evidence Summary[1].
  2. GlobalData Report: Likelihood of Approval and Phase Transition Success Rate Model – (Estradiol + Norethindrone Acetate + Relugolix) in Endometriosis[2].
  3. Health Canada Summary Basis of Decision: Myfembree[3].
  4. MYFEMBREE HCP Website: SPIRIT Trials[4].
  5. FDA Approval Document: 214846Orig1s000 - accessdata.fda.gov[5].

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