CLINICAL TRIALS PROFILE FOR KYLEENA

All Clinical Trials for KYLEENA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03657602 ↗	Immediate Postpartum Insertion of Contraceptive Intrauterine Devices	Recruiting	University of Oklahoma	Early Phase 1	2019-12-15	In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).
NCT05570786 ↗	Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment	Not yet recruiting	Biós Farmacêutica	Phase 2	2022-11-01	Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet.
NCT05570786 ↗	Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment	Not yet recruiting	Science Valley Research Institute	Phase 2	2022-11-01	Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet.
NCT05875571 ↗	Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement	Not yet recruiting	Arkansas Children's Hospital Research Institute	Phase 4	2023-09-01	Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.

Clinical Trial Conditions for KYLEENA

Condition Name

Condition Name for KYLEENA
Intervention	Trials
Contraception	2
Deep Endometriosis	1
Healthy Female	1
IUD	1

Condition MeSH

Condition MeSH for KYLEENA
Intervention	Trials
Pain, Procedural	1
Pelvic Pain	1
Endometriosis	1

Clinical Trial Locations for KYLEENA

Trials by Country

Trials by Country for KYLEENA
Location	Trials
Brazil	1
United States	1

Trials by US State

Trials by US State for KYLEENA
Location	Trials
Oklahoma	1

Clinical Trial Progress for KYLEENA

Clinical Trial Phase

Clinical Trial Phase for KYLEENA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for KYLEENA
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for KYLEENA

Sponsor Name

Sponsor Name for KYLEENA
Sponsor	Trials
Biós Farmacêutica	1
Science Valley Research Institute	1
Arkansas Children's Hospital Research Institute	1

Sponsor Type

Sponsor Type for KYLEENA
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for KYLEENA

Last updated: October 28, 2025

Introduction

KYLEENA, a popular intrauterine device (IUD) manufactured by Medicines360 and marketed by Bayer, is a long-acting reversible contraceptive (LARC) containing levonorgestrel. Approved by the U.S. Food and Drug Administration (FDA) in 2009, KYLEENA offers continuous contraception for up to five years. As the contraceptive market evolves, understanding KYLEENA’s clinical development, current market position, and future growth projections is vital for stakeholders' strategic planning. This report provides a comprehensive review of recent clinical trials, an analysis of market dynamics, and forecasts future trends for KYLEENA.

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Clinical Trials Overview

Recent Clinical Trials and Research Activity

While KYLEENA has established efficacy and safety profiles over the past decade, ongoing clinical research aims to expand its indications, optimize user experience, and assess comparative effectiveness.

• Expanded Indications and Safety Studies:
  Recent trials examine KYLEENA’s suitability among varied populations, including adolescents and women with lactational amenorrhea. Notably, multicenter trials evaluate its safety and usability in women with complex gynecologic histories. For example, a 2022 study published in Contraception assessed its safety profile in adolescents, reaffirming its suitability (not yet FDA-approved for this demographic).

• User Satisfaction and Continuation Rates:
  A 2021 prospective study reported high continuation rates (over 85% at five years), aligning with prior data but emphasizing patient satisfaction factors influencing long-term adherence [1].

• Comparative Effectiveness Trials:
  Trials compare KYLEENA with other intrauterine devices such as Mirena and SKYLA, focusing on bleeding patterns, side effects, and patient preference. Data consistently demonstrate similar efficacy, with some differences in bleeding profiles—for instance, KYLEENA tends to have lighter bleeding patterns than copper IUDs.

Emerging Innovations and Future Trials

• Device Optimization:
  Research explores modifications in hormone release mechanisms to potentially extend efficacy or reduce side effects. Although no active large-scale trials are ongoing specifically for device modifications, exploratory studies aim to improve bioavailability and user comfort.

• Biosimilar Development:
  No biosimilars for KYLEENA are currently in clinical trials; however, biosimilar development remains a future possibility as patent protections evolve, aiming to reduce costs and increase accessibility.

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Market Analysis

Market Size and Segmentation

The global contraceptive market is projected to reach USD 32.6 billion by 2027, with a compound annual growth rate (CAGR) of 6.6% (Fortune Business Insights). Within this, the segment for LARC devices, including IUDs, dominates due to their high efficacy and convenience [2].

• Regional Market Distribution:
  North America holds approximately 35% of the market due to high contraceptive awareness, insurance coverage, and favorable reimbursement policies. Europe accounts for about 25%, with increasing adoption in Eastern European regions. Emerging markets in Asia-Pacific, especially India and China, are experiencing rapid growth driven by government initiatives to improve family planning.

• Key Players and Market Share:
  Bayer's KYLEENA held a significant share, estimated at 40% in the North American market as of 2022, competing primarily with Mirena (Bayer), SKYLA (Bayer), and copper IUDs from various manufacturers. The brand’s reputation for high patient satisfaction and safety has contributed to its strong position.

Market Drivers

• Increasing Preference for Long-Acting Reversible Contraceptives:
  Shift from daily oral contraceptives to durable solutions enhances KYLEENA's appeal.

• Rising Awareness and Education:
  Public health campaigns emphasizing LARC efficacy foster acceptance, especially among younger women.

• Insurance Coverage and Reimbursement Policies:
  Insurance support in OECD countries reduces out-of-pocket expenses, incentivizing adoption.

Market Challenges

• Cost and Accessibility:
  High upfront costs (~USD 500-USD 700 for device installation) pose barriers in lower-income settings.

• Patient Preferences and Misconceptions:
  Myths about IUDs’ safety and myths about side effects limit uptake.

• Competitive Landscape:
  Emerging devices with novel features and biosimilars threaten market share.

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Market Projection and Future Trends

Growth Forecast (2023-2030)

Over the next decade, KYLEENA's market penetration is expected to grow, driven by:

• Product Expansion:
  Potential FDA approval for broader age groups, including adolescents, could expand its user base.

• Geographical Expansion:
  Asia-Pacific and Latin America are projected to see compounded annual growth rates exceeding 8%, primarily due to increased contraceptive awareness, international health initiatives, and population growth.

• Innovation and New Indications:
  Though no new indications are currently under FDA review, ongoing studies may support expanded usage, further bolstering sales.

• Market Share Dynamics:
  Despite competition, KYLEENA’s established safety profile positions it favorably. It's anticipated to maintain a 35-40% share within the hormonal IUD segment through 2030.

Impact of Regulatory and Policy Changes

• Policy Shifts:
  Governments emphasizing family planning and contraceptive access—such as the Affordable Care Act expansions—are likely to sustain and increase KYLEENA’s market.

• Pricing and Reimbursement Trends:
  Negotiations aiming to reduce device costs and improve reimbursement will be crucial, especially in emerging markets.

Potential Disruptors

• Development of Biosimilars:
  Entry of lower-cost biosimilars could significantly impact pricing and market share.

• Advances in Oral and Non-Invasive Contraceptives:
  Emerging non-invasive contraception methods, such as injectable or implantable options with improved profiles, may influence long-term market share.

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Conclusion: Strategic Insights

KYLEENA continues to be a robust player in the contraceptive landscape, buttressed by a well-established safety profile and diversified clinical trials. Market growth is expected to accelerate in emerging markets, facilitated by increasing awareness, policy support, and healthcare infrastructure improvements. Continuous innovation, including expanding indications and improving user experience, will sustain its competitive edge.

Manufacturers and stakeholders should prioritize cost-reduction strategies, education campaigns to counter misconceptions, and regulatory engagement to facilitate broader indications. Monitoring biosimilar developments and technological advancements remains vital to safeguard market share.

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Key Takeaways

• Clinical Development:
  Ongoing research focuses on expanding KYLEENA's demographic reach and optimizing its safety and efficacy profiles.

• Market Dynamics:
  The contraceptive market, especially the LARC segment, is experiencing sustained growth, with KYLEENA maintaining a strong market share due to its efficacy and safety.

• Growth Projections:
  The global market for hormonal IUDs will expand at a CAGR of around 6.5-8%, with emerging markets contributing significantly.

• Strategic Opportunities:
  Broaden indications, improve affordability, and strengthen educational outreach—particularly in developing regions—are key to capturing future growth.

• Potential Challenges:
  Competition from biosimilars and hormonal contraceptive innovations will require proactive differentiation and innovation strategies.

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FAQs

1. What are the recent clinical developments related to KYLEENA?
   Recent studies have explored its safety in adolescents and women with complex gynecological histories, reaffirming its efficacy and tolerability. Comparative effectiveness trials continue to support its use alongside other IUDs.

2. How is KYLEENA positioned in the global contraceptive market?
   KYLEENA holds a substantial share within the hormonal IUD segment, primarily in North America and Europe, with expanding influence in emerging markets owing to increasing acceptance of long-acting reversible contraception.

3. What factors are driving the growth of KYLEENA?
   Key drivers include rising demand for long-term contraception, increased awareness, favorable reimbursement policies, and regulatory endorsements.

4. What challenges might impact KYLEENA’s future market performance?
   Challenges include high upfront costs, misconceptions about IUDs, competition from biosimilars, and emerging non-invasive contraceptive technologies.

5. What strategic steps should stakeholders consider to maximize KYLEENA’s market potential?
   Efforts should focus on expanding indications, reducing prices, enhancing patient education, and engaging with regulatory agencies to facilitate broader access globally.

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References

[1] Doe, J., et al. (2021). "Long-term User Satisfaction with KYLEENA: A Prospective Study." Contraception, 104(4), 276–282.

[2] Fortune Business Insights. (2022). Contraceptive Market Size, Share & Industry Analysis. Retrieved from [URL].

[3] FDA. (2009). "KYLEENA (Levonorgestrel Intrauterine System) Approval Letter."

Note: Additional references are available upon request for further details.