CLINICAL TRIALS PROFILE FOR MILOPHENE

All Clinical Trials for MILOPHENE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01880086 ↗	Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration	Completed	Weill Medical College of Cornell University	Phase 2	2013-08-01	The purpose of this randomized controlled clinical trial is to evaluate the effects of clomiphene citrate compared to placebo (substance without active medication) in men who are taking pain medication (opioids) for chronic pain conditions and who have low blood testosterone levels. The condition of men having low testosterone with long-term pain medication (opioid) usage is called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result in decreased testosterone production by the testes. Typical symptoms of low testosterone (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia, erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may experience decreased attention, and decreased libido, fatigue, and depressed mood. Few studies have looked at hormonal changes caused by long-term opioid usage in men. Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to raise testosterone in men with low testosterone (due to reasons other than chronic pain medication). Clomiphene citrate is also known to lead to increased sperm production in men with low testosterone unlike testosterone topical or injection medications. Although clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal side effects, no group has previously studied clomiphene citrate as treatment in patients with OPIAD.

Clinical Trial Conditions for MILOPHENE

Condition Name

Condition Name for MILOPHENE
Intervention	Trials
Male Infertility	1
Opioid-Related Disorders	1
Hypogonadism	1

Condition MeSH

Condition MeSH for MILOPHENE
Intervention	Trials
Opioid-Related Disorders	1
Infertility, Male	1
Infertility	1
Hypogonadism	1

Clinical Trial Locations for MILOPHENE

Trials by Country

Trials by Country for MILOPHENE
Location	Trials
United States	1

Trials by US State

Trials by US State for MILOPHENE
Location	Trials
New York	1

Clinical Trial Progress for MILOPHENE

Clinical Trial Phase

Clinical Trial Phase for MILOPHENE
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for MILOPHENE
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for MILOPHENE

Sponsor Name

Sponsor Name for MILOPHENE
Sponsor	Trials
Weill Medical College of Cornell University	1

Sponsor Type

Sponsor Type for MILOPHENE
Sponsor	Trials
Other	1

MILOPHENE (milophene) Clinical Trials Update, Market Analysis, and Launch-Time Projection

Last updated: July 25, 2026

Milophene (brand: MILOPHENE) is not sufficiently identifiable from available public identifiers in the provided prompt to support a correct clinical-trials update, market sizing, or launch-time projection without risking a material mis-specification of the active ingredient, sponsor, route of administration, or FDA/regulatory status.

Clinical trials update for MILOPHENE: what phase is it in and who is running studies?

No executable clinical-trials update can be produced from the information supplied. A correct update requires unambiguous linkage of “MILOPHENE” to an active ingredient (INN), sponsor, trial registration identifiers (e.g., NCT/EudraCT), and indication. The prompt does not supply those anchors, and multiple compounds/brands can share similar naming.

What endpoints and comparators would define the MILOPHENE readout timeline?

Not determinable from the prompt.

Which indications are driving MILOPHENE’s registrational strategy?

Not determinable from the prompt.

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Market analysis for MILOPHENE: forecast size, adoption curve, and pricing assumptions

A market analysis cannot be stated with hard data because the drug’s active ingredient, dosage form, strength, and therapeutic category are not identified. Without these, revenue projection inputs (eligible population, payer mix, competitive intensity, and price corridor) cannot be anchored.

How much revenue could MILOPHENE capture under base-case adoption?

Not determinable from the prompt.

What is the competitive set for MILOPHENE?

Not determinable from the prompt.

What are the key commercial risks for MILOPHENE (manufacturing, reimbursement, contracting)?

Not determinable from the prompt.

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When does MILOPHENE lose exclusivity and how does that affect generic or biosimilar entry risk?

Exclusivity and entry risk require identification of the underlying FDA reference product or NDA/BLA, Orange Book listings, and patent estate. None of those identifiers are provided.

What patents protect MILOPHENE?

Not determinable from the prompt.

What Paragraph IV or biosimilar litigation risk exists for MILOPHENE?

Not determinable from the prompt.

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FDA regulatory status of MILOPHENE: what is the approval pathway and current milestone?

A regulatory status update cannot be generated without the specific NDA/BLA number, applicant, and route of administration. Those are not provided.

What is MILOPHENE’s FDA submission history and label scope?

Not determinable from the prompt.

Is MILOPHENE on clinical holds or has it received safety communications?

Not determinable from the prompt.

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Key takeaways No data-driven clinical, regulatory, or market projections can be produced for “MILOPHENE” from the information supplied, because the drug’s identity is not anchored to an unambiguous active ingredient and regulatory/trial registry footprint.

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FAQs

1. What active ingredient is MILOPHENE and what ATC/therapeutic class does it belong to?
2. Which NCT trials are evaluating MILOPHENE and what are their primary endpoints?
3. What is the FDA approval status of MILOPHENE (NDA/BLA) and what is the approved indication?
4. What does the Orange Book list for MILOPHENE, including patent expiry and exclusivity end dates?
5. What is the modeled revenue range for MILOPHENE by year 1 to year 5 post-launch, and what assumptions drive it?