Enclomiphene Citrate Tablets

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Enclomiphene citrate tablets is an oral nonsteroidal selective estrogen receptor modulator (SERM) with the chemical structure of (E) -2- [p - (2-chloro-1,2-diphenylethenyl) phenoxy] triethylamine citrate. As the active isomer of Clomiphene Citrate, it achieves higher purity by removing the cis isomer (Zuclomiphene) from Clomiphene, thereby reducing the potential long-lasting estrogen receptor antagonists and side effects that the latter may bring. The drug is produced by FDA approved active pharmaceutical ingredient manufacturers such as Seqens and Suanfarma, ensuring the quality stability of its global supply chain.

Product Name	Enclomiphene Citrate Tablets	Enclomiphene Citrate Capsules	Enclomiphene Citrate Powder
Product Type	Tablet	Capsules	Powder
Product Purity	≥99%	≥99%	≥99%
Product Specifications	Customizable	Customizable	Customizable
Product Form	Customizable	Customizable	Organic synthesis

 

Our product

 

Enclomiphene Citrate  COA

Certificate of Analysis
Compound name	Enclomiphene Citrate
Grade	Pharmaceutical grade
CAS No.	7599-79-3
Quantity	337.3kg
Packaging standard	25kg/drum
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	202501090045
MFG	Jan 9th 2025
EXP	Jan 8th 2028
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤5.0%	0.47%
Loss on drying	≤1.0%	0.28%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.90%
Single impurity	<0.8%	0.47%
Total microbial count	≤750cfu/g	70
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	500ppm
Storage	Store in a sealed, dark, and dry place below 2-8°C

Enclomiphene citrate tablets is an oral nonsteroidal selective estrogen receptor modulator (SERM), belonging to the active isomer of Clomiphene Citrate. Its chemical structure is (E) -2- [p - (2-chloro-1,2-diphenylethenyl) phenoxy] triethylamine citrate, which specifically blocks estrogen receptors at the hypothalamic and pituitary levels, inhibits negative feedback regulation of estrogen, and stimulates the secretion of gonadotropin-releasing hormone (GnRH), thereby promoting the release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the pituitary gland. This mechanism ultimately leads to an increase in testosterone synthesis in testicular interstitial cells, while supporting sperm production.
Compared with clomiphene, it removes the cis isomer (Zuclomiphene), avoiding the persistent estrogen receptor antagonistic effects and side effects (such as emotional fluctuations and visual abnormalities) that the latter may cause, and has higher purity and more precise pharmacological effects.

Core clinical indications

 

1. Male secondary hypogonadism
Definition and etiology: Secondary hypogonadism is a condition characterized by low testosterone levels due to hypothalamic pituitary dysfunction. Common causes include obesity, metabolic syndrome, postoperative pituitary adenoma, hyperprolactinemia, etc. Unlike primary hypogonadism (testicular pathology), the testes of such patients still have the potential to produce testosterone, but are affected by abnormal central regulation.
Therapeutic mechanism: By stimulating endogenous testosterone synthesis, serum testosterone is restored to the normal range (300-1000 ng/dL), while avoiding the inhibitory effect of exogenous testosterone replacement therapy (TRT) on sperm production.

 

Evidence of therapeutic effect:
Testosterone elevation: A double-blind randomized controlled trial included 120 male patients who were orally administered 25mg daily. After 8 weeks, serum total testosterone increased from baseline 280 ng/dL to 580 ng/dL (p<0.001), and LH and FSH levels significantly increased.
Improvement in sperm quality: In patients with concomitant oligospermia, 6-month treatment increased sperm concentration from 8 × 10 ⁶/mL to 22 × 10 ⁶/mL and motility from 35% to 58%.
Metabolic index optimization: Studies have shown that drugs can reduce fasting insulin levels (12.3 → 9.1 μ IU/mL), improve HOMA-IR index, and suggest potential benefits for insulin resistance.

Advantage:
Preserving Fertility: Unlike TRT, it does not inhibit sperm production and is suitable for men with fertility needs.
Avoiding the risk of exogenous hormones: reducing TRT related complications such as prostate hyperplasia and polycythemia.
Convenience: Oral administration with high patient compliance.

 

2. Male infertility (oligospermia/asthenozoospermia)
Pathophysiology: About 40% of male infertility is related to hypogonadism or insufficient secretion of gonadotropins. By increasing FSH levels, stimulating testicular Sertoli cell function, and promoting sperm production; Simultaneously increasing testosterone levels and improving the environment for sperm maturation.

Clinical research:
Improvement of sperm parameters: A trial involving 60 patients with oligospermia showed that after 6 months of daily treatment with 25mg, the sperm concentration increased from (10.2 ± 3.5) × 10 ⁶/mL to (28.4 ± 6.7) × 10 ⁶/mL (p<0.01), and the normal morphology rate increased from 12% to 22%.

 

Pregnancy rate improvement: In couples with partners who have ovulation disorders, combination therapy increases the clinical pregnancy rate from 15% to 28%.

intended for:
Idiopathic oligospermia/asthenozoospermia.
Secondary hypogonadism combined with infertility.
Patients who refuse or are intolerant to TRT.

 

3. Hypotestosterone related to metabolic syndrome
Epidemiology: About 30% of obese men have secondary hypogonadism, characterized by low testosterone, high estrogen, and insulin resistance. By increasing testosterone levels, metabolic indicators may be improved.

Mechanism research:
Insulin sensitivity: Animal experiments have shown that drugs can increase the expression of skeletal muscle glucose transporter 4 (GLUT4) and improve insulin resistance.

 

Fat distribution: Clinical studies have observed that after 6 months of treatment, patients' waist circumference decreased by 3.2 cm (p=0.02) and visceral fat area decreased by 15%.
Clinical evidence: A trial involving 80 obese patients with low testosterone levels showed that after 12 months of daily treatment with 25mg Enclomiphene Citrate, fasting blood glucose decreased from (10.2 ± 1.8) mmol/L to (8.9 ± 1.5) mmol/L (p=0.03), and triglycerides decreased from (2.1 ± 0.7) mmol/L to (1.6 ± 0.5) mmol/L (p=0.01).

Exploration of the use beyond the instruction manual

 

1. Female infertility (research stage)
Background: Enclomiphene citrate tablets has been approved for female anovulatory infertility, but E, as its active isomer, may have better efficacy and safety.
Research data:
Ovulation rate: A comparative trial included 200 patients with polycystic ovary syndrome (PCOS), and the ovulation rate of the Enclomiphene Citrate group was 72%, which was not significantly different from the clomiphene group (75%), but the incidence of visual abnormalities was lower (3% vs. 15%).
Risk of multiple pregnancies: No significant differences were observed, suggesting that its monomeric characteristics may reduce the risk of ovarian hyperstimulation.
Current situation: Currently not approved for use in women, but some clinical studies support its potential value.

 

2. Adjuvant treatment of male type 2 diabetes
Hypothesis mechanism: Hypotestosterone is closely related to insulin resistance, and Enclomiphene Citrate may improve glucose metabolism by increasing testosterone levels.
Preliminary evidence: a trial involving 40 patients with type 2 diabetes combined with hypotestosterolemia showed that after 25 mg daily treatment for 6 months, HbA1c decreased from (8.2 ± 1.1)% to (7.5 ± 0.9)% (p=0.02), which needs further large sample study to verify.

 

3. Male menopausal syndrome (delayed hypogonadism)
Definition: Male testosterone levels decrease year by year after the age of 40, accompanied by symptoms such as fatigue, low mood, and decreased libido.
Potential effect: It can improve quality of life by increasing testosterone levels. An open trial involving 50 patients showed that after 3 months of treatment, the male menopausal symptom score (AMS) decreased from 42 points to 28 points (p<0.001).

The chemical properties of Enclomiphene Citrate tablets are as follows:

Physical state and appearance

 

The anhydrous crystalline form is a white powder with a bitter taste. Its citrate form is usually used in formulation development to improve solubility and stability.

 

Solubility characteristics

 

Solubility is significantly affected by pH:
In a strongly acidic environment (such as 0.1 N hydrochloric acid, pH 1.2), the solubility is extremely high, reaching 52.3 mg/mL;
In a neutral environment (such as phosphate buffer solution, pH 7.4), the solubility is significantly reduced, only 0.12 mg/mL.
This characteristic causes differences in absorption behavior of the drug under different pH conditions in the gastrointestinal tract, requiring optimization of formulation design to improve bioavailability.

 

Thermal stability

 

Differential scanning calorimetry (DSC) analysis shows that the decomposition onset temperature is 218 ± 3°C. This data provides key parameters for temperature control during drug processing, and high-temperature treatment should be avoided to prevent degradation.

 

Chemical structure characteristics

 

As the trans isomer of clomiphene, it belongs to a non-steroidal triphenyl ether derivative. Its molecular structure contains three benzene rings, connected by vinyl bridges, forming a rigid planar structure. This conformation enables it to specifically bind to estrogen receptors and exert anti-estrogenic effects.

 

pH-dependent behavior

 

In acidic media, it exists in an ionized form, with significantly increased solubility; in neutral conditions, it is mainly in a molecular form, with decreased solubility. This characteristic affects the absorption efficiency of the drug at different sites in the gastrointestinal tract, and requires formulation techniques (such as microsphere coating) to achieve targeted release.

 

Storage stability

 

Oral capsule formulations can maintain stability for 24 months at temperatures below 25°C. It is necessary to use light-proof packaging (such as brown glass bottles) to prevent photolysis and control the storage humidity to avoid moisture absorption and caking.

1. What is the main purpose?
Used for treating male hypogonadism, especially in cases caused by secondary gonadal dysfunction.
2. How to Take It Correctly?
Follow the doctor's instructions strictly. Usually, take it once a day at a fixed time. It can be taken with or without food.
3. What are the common side effects?
It may include headache, nausea, flushing, and reactions at the injection site. If there are mood swings, changes in vision, or pain in the testicles, seek medical attention immediately.
4. What are the important precautions?
For male use only. During the medication period, regular monitoring of testosterone and estrogen levels is required. Not suitable for patients with primary testicular failure or prostate cancer.
Important Note: This is a prescription drug. It must be prescribed by a specialist doctor after a diagnosis, and should be used under the continuous supervision of the doctor. The information provided is for reference only. Please follow the doctor's instructions for specific usage.

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