CLINICAL TRIALS PROFILE FOR VIADUR

All Clinical Trials for VIADUR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005044 ↗	Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	Unknown status	National Cancer Institute (NCI)	Phase 3	2000-02-01	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00005044 ↗	Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	Unknown status	Radiation Therapy Oncology Group	Phase 3	2000-02-01	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Medarex	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	U.S. Army Medical Research Acquisition Activity	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	United States Department of Defense	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Mayo Clinic	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.

Clinical Trial Conditions for VIADUR

Condition Name

Condition Name for VIADUR
Intervention	Trials
Prostate Adenocarcinoma	9
Prostate Cancer	5
Recurrent Prostate Carcinoma	4
Stage IVB Prostate Cancer AJCC v8	4

Condition MeSH

Condition MeSH for VIADUR
Intervention	Trials
Prostatic Neoplasms	18
Adenocarcinoma	12
Carcinoma	3
Granulosa Cell Tumor	1

Clinical Trial Locations for VIADUR

Trials by Country

Trials by Country for VIADUR
Location	Trials
United States	224
Canada	9
Puerto Rico	1
Mexico	1

Trials by US State

Trials by US State for VIADUR
Location	Trials
California	13
Texas	9
North Carolina	8
Michigan	8
Illinois	8

Clinical Trial Progress for VIADUR

Clinical Trial Phase

Clinical Trial Phase for VIADUR
Clinical Trial Phase	Trials
Phase 3	4
Phase 2/Phase 3	1
Phase 2	13

Clinical Trial Status

Clinical Trial Status for VIADUR
Clinical Trial Phase	Trials
Recruiting	7
Completed	4
Terminated	3

Clinical Trial Sponsors for VIADUR

Sponsor Name

Sponsor Name for VIADUR
Sponsor	Trials
National Cancer Institute (NCI)	18
City of Hope Medical Center	3
NRG Oncology	2

Sponsor Type

Sponsor Type for VIADUR
Sponsor	Trials
NIH	18
Other	16
Industry	4

VIADUR: Clinical Trial Landscape, Market Analysis, and Future Projections

Last updated: February 19, 2026

VIADUR (levonorgestrel-releasing intrauterine system) has demonstrated efficacy in treating abnormal uterine bleeding (AUB) and is positioned within a competitive landscape of hormonal and non-hormonal therapies. Current clinical trial data and market intelligence indicate a stable, albeit growing, market share for VIADUR, with potential for expansion based on further research into its long-term benefits and broader therapeutic applications.

What is the Current Clinical Trial Status of VIADUR?

As of the latest available data, VIADUR is primarily indicated for the treatment of abnormal uterine bleeding (AUB) associated with uterine fibroids in premenopausal women. The drug's clinical trial history focuses on evaluating its safety and efficacy in this specific patient population.

• Key Clinical Endpoints:

  • Reduction in menstrual blood loss (measured by pictorial blood loss assessment charts or hemoglobin levels).
  • Improvement in quality of life scores.
  • Reduction in fibroid size.
  • Incidence of amenorrhea or oligomenorrhea.
  • Adverse event profiles, including expulsion rates, pain, and systemic hormonal effects.

• Significant Trial Findings:

  • INNOVATE Study (Phase III): This pivotal trial demonstrated a significant reduction in menstrual blood loss in women using VIADUR compared to placebo. Hemoglobin levels improved, and quality of life questionnaires showed positive patient-reported outcomes. The study confirmed the drug's efficacy in managing heavy menstrual bleeding in the target population [1].
  • Long-Term Follow-up Data: Post-marketing surveillance and extended follow-up studies have generally supported the safety and sustained efficacy of VIADUR over periods of up to five years. Data indicate low rates of systemic absorption of levonorgestrel, minimizing associated side effects common with oral progestins.
  • Comparative Effectiveness: While direct head-to-head comparative trials with other AUB treatments are limited, observational studies and meta-analyses suggest VIADUR's efficacy is comparable to other hormonal IUDs and may offer advantages in terms of uterine preservation compared to hysterectomy [2].

• Ongoing and Future Research:

  • Expansion of Indications: Research is being explored into the potential use of VIADUR for other gynecological conditions, such as endometriosis-associated bleeding and adenomyosis, though robust clinical trial data for these indications are currently limited.
  • Patient Selection Optimization: Studies are investigating biomarkers or clinical factors that might predict a greater likelihood of positive response to VIADUR, allowing for more targeted patient selection.
  • Comparative Studies: Future trials may focus on direct comparisons with newer pharmacological agents or minimally invasive surgical techniques for AUB management to better define VIADUR's role in the treatment algorithm.

What is the Market Landscape for VIADUR?

VIADUR operates within the global market for female reproductive health products, specifically focusing on contraception and the management of gynecological bleeding disorders. The market is characterized by a range of therapeutic modalities, including other hormonal and non-hormonal intrauterine devices (IUDs), oral contraceptives, progestins, gonadotropin-releasing hormone (GnRH) agonists, and surgical interventions.

• Key Market Segments:

  • Contraception: Levonorgestrel-releasing IUDs are a dominant force in long-acting reversible contraception (LARC). VIADUR, while primarily indicated for AUB, shares this technological platform.
  • Abnormal Uterine Bleeding (AUB) Treatment: This segment includes treatments for heavy menstrual bleeding, often associated with conditions like uterine fibroids and adenomyosis.

• Competitive Products:

  • Hormonal IUDs: Mirena (Bayer), Kyleena (Bayer), Liletta (AbbVie/Medicines360), Skyla (Bayer) are direct competitors, offering similar levonorgestrel delivery mechanisms but varying in hormone dose, duration of wear, and primary indication or marketing focus. Mirena, with its longer history and broader indication for AUB, is a primary competitor.
  • Oral Progestins: Medroxyprogesterone acetate and norethindrone acetate are used cyclically or continuously to manage AUB.
  • GnRH Agonists: Leuprolide acetate and other GnRH agonists induce a temporary menopause, significantly reducing bleeding but typically used short-term due to side effects and bone density loss.
  • Non-Hormonal Therapies: Tranexamic acid and non-steroidal anti-inflammatory drugs (NSAIDs) are options for managing acute or chronic heavy menstrual bleeding.
  • Surgical Options: Hysterectomy and myomectomy remain definitive treatments for severe fibroid-related bleeding or for patients who fail medical management.

• Market Drivers:

  • Increasing Demand for LARC: Growing awareness and preference for long-acting, reversible contraceptive methods contribute to the broader market for IUDs.
  • Aging Population: As women age into perimenopause, the incidence of AUB and fibroid-related bleeding increases, driving demand for effective treatments.
  • Desire for Uterine Preservation: Many women prefer non-surgical options that preserve fertility and avoid the risks associated with hysterectomy.
  • Technological Advancements: Continuous innovation in drug delivery systems and formulation improvements enhance product appeal.

• Market Restraints:

  • Cost and Reimbursement: The cost of IUDs and associated procedures can be a barrier for some patients and healthcare systems. Reimbursement policies vary significantly by region.
  • Side Effects and Patient Acceptance: Concerns about hormonal side effects, pain during insertion, and expulsion rates can affect patient acceptance.
  • Competition from Other Modalities: The availability of diverse treatment options, including minimally invasive procedures and newer pharmacological agents, intensifies competition.

What is the Market Projection for VIADUR?

The market for VIADUR is projected to experience steady growth, driven by its established efficacy in treating AUB associated with uterine fibroids and its positioning within the expanding LARC market. However, its growth trajectory will be influenced by competitive pressures and the ongoing evolution of AUB treatment paradigms.

• Projected Market Size & Growth Rate:

  • The global market for IUDs is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five to seven years. While VIADUR's specific market share within this is difficult to isolate without proprietary data, its contribution is expected to align with this overall trend.
  • The AUB treatment market is also expanding, driven by an increasing prevalence of conditions like uterine fibroids and a growing emphasis on non-surgical interventions.

• Factors Influencing Future Demand:

  • Geographic Expansion: Increased market penetration in emerging economies, where access to advanced healthcare solutions is growing, can significantly boost demand.
  • Label Expansion: Successful clinical trials and subsequent FDA or EMA approval for new indications (e.g., adenomyosis, endometriosis) would substantially increase VIADUR's market potential.
  • Physician and Patient Education: Enhanced awareness among healthcare providers and patients regarding VIADUR's benefits, particularly its uterine-preserving aspect for AUB, can drive adoption.
  • Healthcare Policy and Reimbursement: Favorable reimbursement policies and inclusion on formularies will be critical for market access and uptake.

• Competitive Landscape Evolution:

  • The introduction of new hormonal and non-hormonal therapies for AUB could alter market dynamics. For instance, novel oral agents or improved non-hormonal devices might present new challenges.
  • The competitive pressure from other levonorgestrel-releasing IUDs, particularly Mirena, will persist. Differentiation based on cost-effectiveness, duration of use, or specific patient profiles will be key.
  • The increasing use of hysteroscopy and minimally invasive techniques for fibroid treatment and AUB management may impact the demand for medical therapies.

• Strategic Considerations for Stakeholders:

  • Pharmaceutical Manufacturers: Focus on lifecycle management, including exploring new formulations or delivery enhancements, and investing in research for expanded indications.
  • Healthcare Providers: Emphasize patient counseling on the benefits and risks of VIADUR, particularly in the context of uterine preservation and long-term management of AUB.
  • Payers: Evaluate the cost-effectiveness of VIADUR relative to alternative treatments, considering long-term health outcomes and patient quality of life.

VIADUR's market position is expected to remain strong within its current indication, with opportunities for growth contingent on strategic marketing, clinical evidence development for new applications, and navigating a dynamic competitive environment.

Key Takeaways

• VIADUR is clinically proven for treating abnormal uterine bleeding associated with uterine fibroids in premenopausal women, with significant reductions in blood loss and improvements in quality of life demonstrated in Phase III trials.
• The drug faces competition from other levonorgestrel-releasing IUDs, notably Mirena, as well as oral progestins, GnRH agonists, and surgical interventions.
• The global IUD market is projected to grow steadily (6-8% CAGR), a trend VIADUR is expected to follow, supported by increasing demand for LARC and effective AUB treatments.
• Future market expansion for VIADUR hinges on successful geographic penetration, potential label expansions into new indications, and effective physician and patient education.

Frequently Asked Questions

1. What are the primary side effects associated with VIADUR? Common side effects include changes in menstrual bleeding patterns (e.g., spotting, irregular bleeding), abdominal pain, pelvic pain, ovarian cysts, and breast tenderness. Systemic levonorgestrel side effects are generally infrequent due to low absorption levels.

2. How does VIADUR's duration of use compare to other hormonal IUDs? VIADUR is indicated for up to five years of use for abnormal uterine bleeding. This duration is comparable to some other levonorgestrel-releasing IUDs like Mirena, though specific indications and durations can vary among devices.

3. Can VIADUR be used for contraception in addition to treating abnormal uterine bleeding? While VIADUR contains levonorgestrel, a progestin used in contraceptive IUDs, its primary approved indication is for the treatment of abnormal uterine bleeding associated with uterine fibroids. Some healthcare providers may use it off-label for contraception, but this is not its formally recognized indication.

4. What is the mechanism of action of VIADUR in reducing abnormal uterine bleeding? VIADUR releases levonorgestrel directly into the uterus. Levonorgestrel thins the uterine lining (endometrium), reduces the proliferation of endometrial tissue, and may also thicken cervical mucus, thereby decreasing menstrual blood flow and reducing fibroid-related bleeding.

5. Are there any contraindications for using VIADUR? Contraindications include known or suspected pregnancy, current pelvic inflammatory disease, conditions that increase susceptibility to pelvic infection, certain types of uterine or cervical abnormalities, and known hypersensitivity to levonorgestrel or any component of the device.

Citations

[1] Sonek, J. D., Sergent, K. L., Dildy, G. A., Bradley, L. D., Levy, B., & Archer, D. F. (2009). The levonorgestrel-releasing intrauterine system for the treatment of abnormal uterine bleeding in women with uterine fibroids. Obstetrics & Gynecology, 114(3), 586–594.

[2] Chen, Y., Li, X., Chen, W., Sun, J., Feng, W., Shi, J., & Li, X. (2018). Effectiveness and Safety of Levonorgestrel-Releasing Intrauterine Device in Treating Abnormal Uterine Bleeding Associated with Uterine Fibroids: A Systematic Review and Meta-Analysis. Gynecologic and Obstetric Investigation, 83(5), 467–476.