Last reviewed · How we verify
Fluotestin (FLUOXYMESTERONE)
At a glance
| Generic name | FLUOXYMESTERONE |
|---|---|
| Drug class | Androgen |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1956 |
Approved indications
- Bilateral Anorchia
- Congenital myotonia, autosomal dominant form
- Deficiency of testosterone biosynthesis
- Delayed puberty
- Hormone receptor positive malignant neoplasm of breast
- Klinefelter's syndrome, XXY
- LHRH Deficiency
- Male hypogonadism
- Noonan's syndrome
- Primary Hypogonadism due to Bilateral Torsion
- Primary Hypogonadism due to Orchitis
- Undescended testicle
Common side effects
- Virilization (females)
- Amenorrhea and menstrual irregularities (females)
- Inhibition of gonadotropin secretion
- Gynecomastia (males)
- Penile erections - excessive frequency and duration (males)
- Hirsutism
- Male pattern baldness
- Seborrhea
- Acne
- Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates
- Nausea
- Increased or decreased libido
Serious adverse events
- Hepatocellular neoplasms
- Peliosis hepatis
- Cholestatic jaundice
- Alterations in liver function tests
- Suppression of clotting factors II, V, VII, and X
- Bleeding in patients on concomitant anticoagulant therapy
- Polycythemia
- Oligospermia (males)
- Anaphylactoid reactions
- Hypersensitivity skin manifestations
Drug interactions
- warfarin
Key clinical trials
- A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control (PHASE3)
- Stellest Lens Wear in Adult Progressing Myopes (NA)
- Hybrid Assistive Limb Application in Multiple Sclerosis Patients (NA)
- Myopia Control With a Innovative Spectacle Lens (NA)
- Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease (NA)
- Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection (PHASE3)
- Effectiveness of Myopia Control Interventions : A Comparison of Myopia Control in European Children, Adolescents and Young Adults With Defocus Incorporated Multiple Segments (DIMS) and Highly Aspherical Lenslets (HAL) Spectacles, Atropine, Lenses and Combined Treatments
- Highly Aspherical Lenslet (HAL) and Binocular Vision (BV) Disorders [HALT X(T) Study] (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluotestin CI brief — competitive landscape report
- Fluotestin updates RSS · CI watch RSS