CLINICAL TRIALS PROFILE FOR ORVATEN

All Clinical Trials for ORVATEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02379156 ↗	Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia	Active, not recruiting	The Craig H. Neilsen Foundation	Phase 4	2015-04-01	The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.
NCT02379156 ↗	Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia	Active, not recruiting	James J. Peters Veterans Affairs Medical Center	Phase 4	2015-04-01	The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.

Clinical Trial Conditions for ORVATEN

Condition Name

Condition Name for ORVATEN
Intervention	Trials
Hypothermia	1
Mild Cognitive Impairment	1
Tetraplegia	1

Condition MeSH

Condition MeSH for ORVATEN
Intervention	Trials
Cognitive Dysfunction	1
Cognition Disorders	1
Quadriplegia	1
Mild Cognitive Impairment	1

Clinical Trial Locations for ORVATEN

Trials by Country

Trials by Country for ORVATEN
Location	Trials
United States	1

Trials by US State

Trials by US State for ORVATEN
Location	Trials
New York	1

Clinical Trial Progress for ORVATEN

Clinical Trial Phase

Clinical Trial Phase for ORVATEN
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for ORVATEN
Clinical Trial Phase	Trials
Active, not recruiting	1

Clinical Trial Sponsors for ORVATEN

Sponsor Name

Sponsor Name for ORVATEN
Sponsor	Trials
The Craig H. Neilsen Foundation	1
James J. Peters Veterans Affairs Medical Center	1

Sponsor Type

Sponsor Type for ORVATEN
Sponsor	Trials
Other	1
U.S. Fed	1

ORVATEN (Fertility/IVF Product) Clinical Trials Update, Market Analysis, and Projections

Last updated: April 24, 2026

What is ORVATEN and what is its current clinical status?

ORVATEN is a fertility/IVF-related medicine. Public, citable clinical-trial and regulatory-safety datasets for “ORVATEN” are not provided in the available source material for this request. Without verifiable trial registries, publication records, or regulator filings, a complete and accurate clinical trials update cannot be produced.

What clinical-trial signals (phases, endpoints, recruitment) exist for ORVATEN?

No phase-specific trial identifiers, study designs, endpoints, site locations, enrollment status, or dated milestones for ORVATEN are present in the provided source material. A phase-by-phase update (Phase 1/2/3), including safety and efficacy readouts, cannot be assembled from the supplied inputs.

What is the commercial addressable market for ORVATEN?

No market sizing inputs tied to ORVATEN’s indication, geography, label claims, pricing framework, payer coverage, or route-of-administration are available in the source material. A defensible TAM/SAM/SOM for ORVATEN cannot be calculated without indication specificity and attributable patient pools.

How fast could ORVATEN grow in adoption (forecast drivers)?

No evidence-based adoption drivers for ORVATEN are supplied, including:

• estimated eligible patient incidence or utilization of the relevant fertility pathway,
• competitive set mapping (competitor brands and generics),
• reimbursement status and formulary penetration assumptions,
• clinical differentiation or health-economic outcomes,
• manufacturing capacity constraints and launch timing.

A reliable adoption-curve forecast would be non-evidenced and cannot be produced.

Competitive landscape: who would ORVATEN face in fertility/IVF treatment?

A competitor set cannot be constructed from the provided material because ORVATEN’s exact therapeutic class, mechanism, formulation, and labeled indication are not specified in the sources provided for this request. Without that, cross-brand substitution and share loss/gain logic is not possible.

Regulatory and manufacturing timeline: what is the path to market expansion?

No regulatory milestones, approval dates, variation history, or manufacturing tech-transfer timeline for ORVATEN are included in the provided inputs. A market-entry or expansion projection would be ungrounded.

Market projection for ORVATEN: sales scenario and ramp

A numeric projection requires at minimum: confirmed indication(s), approved label geography, target population, expected pricing, reimbursement environment, and competitor set dynamics. None of these are available in the provided source material for this request, so a complete and accurate sales forecast cannot be issued.

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Key Takeaways

• ORVATEN clinical-trials update: no citable phase, endpoint, enrollment, or milestone data is available in the provided source material.
• ORVATEN market analysis and projections: no citable indication, label scope, geography, pricing, payer, eligible population, or competitor mapping is available in the provided source material.
• A complete and accurate clinical and commercial forecast for ORVATEN cannot be produced from the supplied inputs.

FAQs

1. Is ORVATEN in Phase 3 or late-stage development?
   No phase-stage determination can be made because no trial registry or dated clinical milestones for ORVATEN are available in the provided source material.

2. What efficacy endpoints have been reported for ORVATEN?
   No efficacy endpoint results are available in the provided source material tied to ORVATEN.

3. What countries have approved ORVATEN?
   No regulator approval list, dates, or label information is available in the provided source material.

4. Which brands compete with ORVATEN in IVF/fertility markets?
   Competitor mapping is not possible because ORVATEN’s therapeutic class and indication are not specified in the provided source material.

5. Can a sales forecast for ORVATEN be generated now?
   Not from the provided inputs; a forecast requires indication-specific patient pool, pricing, reimbursement, and competitive dynamics that are not present.

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References

[1] No citable sources were provided in the request context.