Enclomiphene 60caps

Enclomiphene 
Manufacturer: Paragon Pharmatech
Strength & Size: 12.5 mg per capsule · 60 vegetarian capsules per bottle
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Short Facts
Product name
Enclomiphene
Other names used
Enclomifene; (E)-clomiphene; trans-clomiphene; ICI-46476; RMI-16289; tentative brand: Androxal (development name). (Wikipedia)
Active ingredient
Enclomiphene (a selective estrogen receptor modulator, SERM). (PubChem)
Strength per capsule & bottle size
12.5 mg per capsule; 60 capsules per bottle. (as specified)
Chemical structure (description)
Triphenylethylene/stilbene SERM with an (E) double bond configuration; tertiary amine side chain (diethylamino-ethoxy) attached to a para-phenoxy group; overall framework analogous to clomiphene but enriched for the anti-estrogenic enclomiphene isomer. Molecular formula (base): C26H28ClNO. Typical marketed salt in research: citrate (base + citric acid). (PubChem)
CAS numbers
•    Enclomiphene (free base): 15690-57-0. (medkoo.com)
•    Enclomiphene citrate: 7599-79-3. (PubChem)
•    Enclomiphene HCl (occasionally referenced for analytical standards): 14158-65-7. (sigmaaldrich.com)
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Overview of the Active Ingredient
What it is.
Enclomiphene is the anti-estrogenic stereoisomer of clomiphene. As a SERM, it primarily antagonizes estrogen receptors in the hypothalamus and pituitary, which reduces estrogen’s negative feedback on the hypothalamic–pituitary–gonadal (HPG) axis. The result is an increase in GnRH pulsatility from the hypothalamus and elevations in LH and FSH from the pituitary—driving endogenous testosterone production in the testes while preserving spermatogenesis. (Wikipedia)
Why it matters.
In men with secondary hypogonadism (especially obesity-associated), exogenous testosterone can normalize serum testosterone but commonly suppresses sperm production; by contrast, enclomiphene raises testosterone while maintaining sperm counts because it stimulates the endogenous axis rather than bypassing it. Multiple randomized and controlled studies have shown consistent increases in total testosterone (TT) and gonadotropins with sperm parameters preserved within normal ranges. (PubMed)
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How It Works (Pathways & Mechanism)
Primary mechanism — HPG axis disinhibition
•    Enclomiphene → ER antagonism (hypothalamus/pituitary) → reduced estrogen negative feedback
•    ↑ GnRH pulses (hypothalamus) → ↑ LH & FSH (anterior pituitary)
•    LH → Leydig cells (testis) → ↑ intrinsic testosterone synthesis
•    FSH → Sertoli cells → supports spermatogenesis
•    Outcome: ↑ Serum TT, preserved fertility, rhythmic endogenous production (Wikipedia)
Text diagram (for later conversion to a clean schematic):
Hypothalamus (↓ER signaling) ⇒ ↑ GnRH → Pituitary ⇒ ↑ LH / FSH → Testis
• LH ⇒ Leydig cells ⇒ ↑ Testosterone
• FSH ⇒ Sertoli cells ⇒ Spermatogenesis maintained
Feedback: Testosterone → aromatase → estradiol → (blocked at ER by enclomiphene)
Pharmacologic notes
•    SERM class; anti-estrogenic profile at the axis in men (zuclomiphene, the Z isomer, is relatively more estrogenic—hence the value of the E-isomer enrichment). (Wikipedia)
•    Commonly studied as the citrate salt for oral administration in trials. (genome.jp)
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What Studies Have Shown (Selected Clinical Evidence)
Randomized Phase II comparison vs. topical testosterone
•    Wiehle et al., Fertility & Sterility (2014): Enclomiphene raised testosterone while preventing oligospermia, in contrast to transdermal testosterone which normalized TT but suppressed sperm counts. (fertstert.org)
Prospective studies & pooled analyses
•    Kim et al., 2016 (PubMed): Across trials in men with secondary hypogonadism, enclomiphene consistently increased TT, LH, and FSH to normal ranges and maintained sperm concentrations in the normal range; testosterone gel raised TT but did not maintain sperm counts. (PubMed)
•    Kaminetsky et al., 2013 (J Sex Med/Andrology): Endogenous TT restoration with elevated sperm counts at 3–6 months; LH/FSH increases were aligned with physiological stimulation rather than exogenous replacement. (Wiley Online Library)
Additional development data
•    Phase III programs (e.g., Androxal/ZA-305) achieved normal 24-hour TT in a majority while meeting semen co-endpoints, per development reports and registry summaries; these informed later regulatory discussions. (biocentury.com)
Synthesis across trials
•    Signal is robust for TT restoration with axis-preserving gonadotropin and sperm effects. Safety in short-to-mid-term studies has generally been acceptable, with adverse events typically mild (e.g., headache, hot flashes), though long-term safety data remain more limited than for older agents. (PMC)
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Usage & Quality
Intended use (scientific/educational context)
Enclomiphene is used in clinical research and, in some locales, compounded for prescription under physician oversight to address secondary hypogonadism while aiming to preserve fertility. It’s frequently discussed as an option for men seeking symptomatic relief of low testosterone without compromising spermatogenesis. Note: It is not FDA-approved; access pathways (where legal) are typically compounding pharmacies operating under local regulations. (Drugs.com)
Quality considerations (manufacturer perspective)
•    Identity & purity: Confirmed by NMR/LC-MS and chiral/ratio assessments to ensure enrichment for enclomiphene (E-isomer).
•    Salt form: Clearly specify citrate vs. base; document counter-ion content and assay as free-base equivalent. (selleckchem.com)
•    Stability & packaging: Protect from light/moisture; validate shelf life and assay over time.
•    Testing: Residual solvents, heavy metals, microbial limits; if formulated, content uniformity and dissolution per pharmacopeial standards where applicable.
•    GMP manufacturing: Batch records and CoA should include assay, impurities profile, and isomeric purity; analytical methods validated for linearity, specificity, precision.
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Compliance & Safety Notes
•    Regulatory status: As of October 20, 2025, enclomiphene is not FDA-approved for any indication in the U.S.; the historical development program (Androxal) did not receive approval. Availability in some markets occurs via compounding with a prescription; regulations vary by jurisdiction. (Drugs.com)
•    Clinical oversight: Use should be physician-directed with baseline and follow-up labs (TT, LH/FSH, estradiol, SHBG, hematocrit, lipid profile; semen analysis if fertility is a goal).
•    Adverse events & cautions: Potential for visual disturbances, mood changes, hot flashes, GI upset, and thromboembolic risk is theorized from SERM class experience; counsel patients about warning symptoms and interactions.
•    Population considerations: Evaluate for contraindications (e.g., active liver disease, hormone-sensitive neoplasia risk).
•    Labeling/claims: Marketing materials should avoid disease claims and remain consistent with local law given the investigational/off-label status. (OPSS)
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Strong Benefits (5 Key Points)
1.    Restores endogenous testosterone by re-activating the HPG axis rather than replacing hormones exogenously. (PubMed)
2.    Maintains spermatogenesis and fertility potential while increasing TT—unlike many exogenous testosterone regimens. (fertstert.org)
3.    Physiologic LH/FSH signaling, supporting rhythmic, feedback-integrated hormone production. (Wikipedia)
4.    Oral administration with favorable short- to mid-term tolerability in trials; lab-guided dosing strategies are feasible. (PubMed)
5.    Isomer-specific profile (E-isomer) offers a more anti-estrogenic, pro-gonadotropic effect than the mixed isomer drug clomiphene. (Wikipedia)
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References (selected)
•    Kim ED et al. Oral enclomiphene citrate raises testosterone and maintains sperm concentrations in hypogonadal men. 2016. PubMed. (PubMed)
•    Wiehle RD et al. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: randomized phase II vs topical testosterone. Fertil Steril. 2014. (fertstert.org)
•    Kaminetsky J et al. Oral enclomiphene citrate stimulates endogenous testosterone and sperm counts in men with secondary hypogonadism. 2013 (J Sex Med/Andrology). (ScienceDirect)
•    Rodriguez KM et al. Enclomiphene Citrate for the Treatment of Secondary Male Hypogonadism. 2016 review. (PMC)
•    PubChem & KEGG entries for enclomiphene/enclomiphene citrate (structure, identifiers, salts). (PubChem)
•    Registry/press summaries of Phase III Androxal programs (ZA-305 and safety extensions). (ClinicalTrials)
•    CAS confirmations for base/citrate/HCl salts. (medkoo.com)
•    Regulatory status summaries (FDA approval status and compounding context). (Drugs.com)
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Remember, this product is intended for research purposes only and should not be used for human consumption without proper medical guidance. As with any supplement, it is important to prioritize your health and safety, and to consult with a healthcare professional if you have any underlying health concerns before incorporating this product into your routine.
This product is not a food product. By acquiring this product, you are in full knowledge that it’s not a food, nor is it for human consumption and it’s for market research purposes only