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
IUD	1
IUD Insertion Complication	1
Pelvic Pain	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
Science Valley Research Institute	1
Arkansas Children's Hospital Research Institute	1
University of Oklahoma	1

Sponsor Type

Sponsor Type for KYLEENA
Sponsor	Trials
Other	4

Last updated: May 20, 2026

Kyleena clinical trials update, market analysis, and forecast for levonorgestrel intrauterine system (IUS)

Kyleena (levonorgestrel) is an FDA-approved 19.5 mg intrauterine system indicated for prevention of pregnancy. The product is commercially established, with no late-stage “pipeline” trials in the public domain that materially change near-term market share or supply. For forecasting, Kyleena’s revenue trajectory is driven primarily by replacement cycles (existing users), penetration vs. LNG IUD competitors, and price/market access rather than by incremental clinical trial readouts.

What clinical trials matter for Kyleena right now?

Bottom line: The most market-relevant “clinical trial” activity for Kyleena is ongoing post-marketing monitoring and label maintenance rather than new efficacy endpoints that would reset exclusivity or expand indication scope.

What trials are typically still active for Kyleena products?

Kyleena is usually not associated with Phase 3 programs in public registries comparable to new drug launches because the key performance dossier supporting approval is already in place. Remaining evidence generation generally falls into:

• Post-authorization safety surveillance (e.g., adverse event reporting and pharmacoepidemiology)
• Real-world performance cohorts (bleeding patterns, continuation rates, device retention and expulsion rates)
• Device handling and population subgroup evaluations (device insertion techniques, compliance-adjacent adherence proxies)
• Pharmacovigilance and risk management plan updates required by regulators

Does Kyleena have new Phase 3 readouts changing competitive positioning?

No public Phase 3 catalyst is identifiable from the core, approval-driving dossier. Without a demonstrable new efficacy or expanded indication milestone, near-term market dynamics remain replacement-cycle and competitive substitution driven.

What is Kyleena’s market position and who competes with it?

Bottom line: Kyleena competes in the LNG IUD category with other levonorgestrel intrauterine systems. Competitive pressure comes from branded and authorized LNG-IUS offerings, formulary access, and price.

Key comparable products (LNG IUDs)

Kyleena’s direct commercial comparisons are generally framed against:

• Mirena (levonorgestrel IUS, longer duration marketed in many geographies depending on label)
• Liletta (levonorgestrel IUS)
• Skyla (levonorgestrel IUS, shorter duration)

How does Kyleena typically win?

Kyleena’s commercial appeal is usually tied to:

• A smaller LNG IUS option profile versus some longer-duration LNG IUDs, supporting onboarding for patients and clinicians seeking shorter/medium duration
• Clinic workflow fit and local coverage decisions
• Switch-and-replace behavior from other IUDs and oral contraception, with continuation driven by side-effect experience and provider familiarity

Which regions are most material for market sizing?

Forecasting depends on jurisdiction because uptake, coverage, and reimbursement differ. For US-focused planning, Kyleena is constrained by:

• Mature contraceptive market penetration
• Competitive substitutability within LNG IUDs
• Payer policies (commercial and government formularies), which can shift share materially during contracting cycles

How big is the Kyleena revenue opportunity and what drives growth?

Bottom line: Kyleena growth is mainly replacement-driven within contraceptive users and is capped by category saturation. Net growth is the combined effect of:

• New-user penetration (starter demand)
• Continuation and switching behavior
• Price and net reimbursement, which can move more than volume once category share is stable

Core demand model (high-level)

A workable market projection framework is:

1. Eligible population and contraception prevalence
2. Annual new LNG IUD initiations
3. Device retention and expulsion rates, which influence effective continuation
4. Replacement cycles as devices reach labeled duration
5. Share-of-category dynamics vs Mirena/Liletta/Skyla during payer contracting and clinical preference shifts
6. Net pricing trends and channel mix

Kyleena exclusivity and generic entry risk: what does it mean for the forecast?

Bottom line: The forecast risk is less about “generic entry” in the conventional small-molecule sense and more about device-market substitution and whether any authorized alternatives materially displace Kyleena within the LNG IUS segment.

What are the practical “entry barriers” for competing LNG IUS products?

Even when active ingredient is the same class (levonorgestrel), substitution is shaped by:

• Device-specific regulatory pathway and approvals
• Quality/CMC requirements and device performance requirements
• Clinician and payer trust based on historical outcomes and label structure
• Reimbursement negotiations that can favor specific SKUs and durations

What is the competitive landscape likely to do over the next 3 to 5 years?

Bottom line: Expect category-level stability with periodic share shifts driven by payer contracting, patient/provider preference, and any label or duration framing that makes one LNG IUS the “default” choice.

What share-moving variables have the most impact?

• Formulary tiers and prior authorization requirements (if used)
• Net price discounts tied to volume commitments
• Provider-specific adoption patterns and clinic purchasing models
• Patient counseling outcomes that influence device selection at initiation
• Switching after discontinuation from competing LNG IUDs

Clinical trial update implications: does any new data likely expand the addressable market?

Bottom line: Without a new label expansion (new indication, new duration, or new method of use with clear differentiation), clinical trial activity does not typically expand the addressable market for an established contraception device. That makes near-term market projection more sensitive to contracting and replacement cycles than to clinical endpoints.

Market projection scenarios for Kyleena (3-year and 5-year view)

Because the prompt requests “market analysis and projection” without providing any geography, launch year baseline, or revenue starting point, the only defensible projection is scenario logic tied to category mechanics. The projections below are directional, designed for business planning inputs.

Scenario A: Stable share, modest net price pressure (base case)

• Initiation demand remains steady
• Replacement cycles support volumes for users already initiated
• Net price declines modestly due to competitive contracting
• Net revenue: slow growth to low single digits, driven mainly by population and utilization, offset by price

Scenario B: Share gains from formulary wins (upside)

• Kyleena becomes the default LNG IUS within key payer plans
• Providers shift initiation choices due to coverage and counseling simplicity
• Net revenue growth: moderate, with category penetration and incremental share

Scenario C: Formulary displacement or stronger competitor momentum (downside)

• Payer contracting favors competitor LNG IUS offerings
• Clinician adoption shifts through purchasing or clinical confidence patterns
• Net revenue: flat to decline, driven by share compression and price pressure

What should an investor or commercial team watch?

Bottom line: Watch payer contracting cycles and LNG IUS mix shifts. Clinical trial updates are secondary unless they change label, duration framing, or safety profile in a way that affects adoption.

Leading indicators

• Formulary tier changes for LNG IUD SKUs
• New or updated clinical guideline language favoring one LNG IUS as first-line
• Sales channel shifts in women’s health practices and IDN purchasing patterns
• Any regulatory label updates that affect duration messaging or patient selection

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Key Takeaways

• Kyleena’s near-term performance is driven by contraceptive adoption and replacement cycles rather than by new Phase 3 catalysts.
• Market upside and downside risk is primarily payer-driven substitution within the LNG IUD category (Kyleena vs. Mirena/Liletta/Skyla), not by generic “entry” in the traditional small-molecule sense.
• A credible forecast framework is initiation mix plus replacement-driven volumes, adjusted for net price and contracting-driven share changes.

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FAQs

1. How does Kyleena compare with Mirena and Liletta for market uptake and payer preference?
2. What are the main drivers of continuation and replacement demand for levonorgestrel IUS products like Kyleena?
3. Do any late-stage clinical trial results commonly change LNG IUD adoption patterns?
4. What label or duration changes most often shift share across LNG IUD brands?
5. What contracting signals predict whether Kyleena will gain or lose formulary share in the next cycle?

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References

1. FDA. Product label information for Kyleena (levonorgestrel intrauterine system). U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. Kyleena (levonorgestrel intrauterine system) search results. U.S. National Library of Medicine.