Enclomiphene Citrate

Enclomiphene citrate is the trans isomer of clomiphene, a non-steroidal selective estrogen receptor modulator that blocks estrogen feedback at the pituitary so.

Human trialsNon-peptide compound reference

Also known as: trans-Clomiphene citrate, (E)-Clomiphene citrate, Androxal, Enclomid, Clomiphene B citrate, Enclomiphene citrate (USAN), UNII J303A6U9Y6, MFCD00058322

(how we review)

Dosing & scaling, explained

Amounts reported for Enclomiphene Citrate are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.

No source-supported amount ladder is shown

Enter a target amount only from your own reviewed source. The calculator can convert it into concentration, volume and device markings, but it will not infer an amount from product availability or another compound.

Only mcg or mg amounts are retained. The calculator derives mL, syringe units or pen clicks from the current vial strength, water volume and device.

No independently verified schedule

Clinical context

Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.

Storage, handling and interpretation

Product identity

Verify the exact compound, formulation and amount against the product label or certificate before calculation.

Storage & handling

Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.

Prepared solutions

Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.

Reported protocols for Enclomiphene Citrate

What published studies and recent community write-ups report about amounts, timing and course length. 3 clinical and 2 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical3 rows
Phase 2 dose-ranging pharmacodynamic and pharmacokinetic study48 men with secondary hypogonadism (total testosterone below 350 ng/dL, LH below 12 IU/L); 44 completed per protocol6.25 mg, 12.5 mg or 25 mg (versus 5 g of transdermal testosterone gel)Once daily, taken between 7:00 and 10:00 in the morningOral capsule6 weeks of continuous daily dosing, with 24-hour hormone profiles on day 1 and day 42Effects on LH and testosterone persisted for at least a week after stoppingBJU International (PubMed)2013
After 6 weeks, morning total testosterone averaged 604 ng/dL on 25 mg versus 500 ng/dL on testosterone gel, and all three doses raised testosterone into the normal range while pushing LH and FSH above normal; the gel suppressed both gonadotropins. The authors judged 12.5 mg and 25 mg the useful doses, with 6.25 mg giving a less reliable response. The study was sponsored and partly authored by the drug's developer.
Two parallel Phase 3 trials versus testosterone gel (ZA-304 and ZA-305)Overweight men aged 18-60 with secondary hypogonadism (total testosterone 300 ng/dL or less, LH below 9.4 IU/L)Two daily oral doses, reported by secondary sources as the program's 12.5 mg and 25 mg capsulesOnce dailyOral, double-dummy against AndroGel 1.62%16 weeksNone describedBJU International (PubMed)2016
Both enclomiphene doses raised total testosterone, LH and FSH and kept sperm concentration in the normal range, while testosterone gel raised testosterone but lowered LH and FSH and markedly reduced sperm counts. The published abstract names two doses without stating them; the 12.5 mg and 25 mg figures come from the developer's earlier trials and later reviews. An earlier Phase 2 trial (NCT01270841) from the same program reported the same pattern of preserved sperm counts.
British Society of Sexual Medicine position statementMen with testosterone deficiency, especially those who want to preserve fertility or cannot use injections or gelsBegin at 6.25 mg; increase up to 25 mg; may be raised to 50 mg if the clinical or biochemical response is inadequateOnce daily, increasing weekly as toleratedOralNot fixed; the statement notes a retrospective series with a median 8.9 months of treatmentNot describedWorld Journal of Men's Health2026
The 2026 statement recommends specialist-only, research-framework use because the drug is unlicensed in the UK and the evidence comes from small, short studies. It summarizes a retrospective comparison in which 30% of enclomiphene patients took 12.5 mg daily and 70% took 25 mg daily against clomiphene 50 mg every other day, and lists headache (1.6%), hot flushes (1.1%), nausea (1.0%), muscle spasms (0.9%) and dizziness (0.7%) as the reported undesirable effects.
Community-reported2 rows
Evidence and risk summary for off-label use12.5 mg and 25 mg are the trial doses; amounts above 25 mg a day have not been tested in controlled trialsOnce dailyOral, compoundedNot fixed; the page describes follow-up labs at roughly 4-6 weeks and then every 3-6 monthsNot describedCommunity resource2025
This 2025 page is a consumer-facing evidence summary rather than a protocol. It states that no FDA-approved prescribing information exists, that the drug is available only off-label through compounding, and that any starting dose or titration should come from a prescriber who has reviewed testosterone, LH, FSH, estradiol and blood count results.
Research-vendor listing (format only)12.5 mg capsules; third-party assays of recent lots measured 11.92-14.75 mg per capsuleNot statedOral capsules; the vendor also lists a liquid form; sold for laboratory research onlyNot statedNot statedCommunity resource2026
This is a vendor page, not a protocol. The capsule strength matches the lower trial dose, and the published certificates show lot-to-lot content ranging from about 5% under to 18% over label, which matters for anyone comparing a research capsule with a pharmacy-compounded one. The page gives no dosing information.

How a course is commonly described

  1. Week 1Clinical

    The BSSM statement describes starting at 6.25 mg once daily by mouth, the lowest dose tested in the Phase 2 dose-ranging study.

  2. Weeks 2-4Clinical

    The dose is raised weekly as tolerated to 25 mg daily, with a further increase to 50 mg daily only if the clinical or biochemical response is inadequate. The 50 mg step has no controlled-trial data behind it.

  3. Weeks 6-16 (trial comparison)Clinical

    The trials themselves used fixed daily doses rather than titration: 6 weeks at 6.25, 12.5 or 25 mg in the Phase 2 study and 16 weeks in the Phase 3 trials. Testosterone rose within 2 weeks and stayed elevated for at least a week after the last dose.

  • Enclomiphene is an oral tablet or capsule, not an injectable peptide, so there is no reconstitution or syringe math. Every published human dose is 6.25-25 mg once a day.
  • The FDA declined to approve it in December 2015 because the Phase 3 design was judged inadequate to show clinical benefit, not because of a safety signal; the drug remains unapproved everywhere and is prescribed only off-label through compounding pharmacies.
  • The titration pattern above is a specialist society's suggestion, not a trial result. The rows record what sources report, not endorsements of use.
Sources for this section (7)
  1. Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and PharmacokineticsBJU International (PubMed)2013Clinical
  2. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosteroneFertility and Sterility (PubMed)2014Clinical
  3. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacementBJU International (PubMed)2016Clinical
  4. British Society of Sexual Medicine: Position Statement for the Potential Use of Enclomiphene in the Treatment of Male HypogonadismWorld Journal of Men's Health2026Clinical
  5. Repros Therapeutics Receives Complete Response Letter From FDA for EnclomipheneU.S. Securities and Exchange Commission (Repros Therapeutics press release)2015Clinical

Plus 2 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

Enclomiphene citrate is the trans isomer of clomiphene, a non-steroidal selective estrogen receptor modulator that blocks estrogen feedback at the pituitary so that LH and FSH rise and the testes make more of their own testosterone. Repros Therapeutics developed it under the name Androxal for secondary hypogonadism in overweight men who wanted to keep their fertility, ran Phase 2 and Phase 3 trials at 12.5 mg and 25 mg a day against testosterone gel, and received an FDA Complete Response Letter in December 2015 asking for new Phase 3 studies; the European application was not approved either and development was discontinued in 2021. It is an oral small molecule rather than a peptide, so there is no vial or reconstitution involved, and it reaches patients today only as a compounded prescription or a research-grade product.

What researchers are exploring

These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.

  • 1

    Endocrine & reproductive

    Hormonal, reproductive and sexual-function research.

  • 2

    Phase 2 dose-ranging pharmacodynamic and pharmacokinetic study

    After 6 weeks, morning total testosterone averaged 604 ng/dL on 25 mg versus 500 ng/dL on testosterone gel, and all three doses raised testosterone into the normal range while pushing LH and FSH above normal; the gel.

  • 3

    Two parallel Phase 3 trials versus testosterone gel (ZA-304 and ZA-305)

    Both enclomiphene doses raised total testosterone, LH and FSH and kept sperm concentration in the normal range, while testosterone gel raised testosterone but lowered LH and FSH and markedly reduced sperm counts. The.

  • 4

    British Society of Sexual Medicine position statement

    The 2026 statement recommends specialist-only, research-framework use because the drug is unlicensed in the UK and the evidence comes from small, short studies. It summarizes a retrospective comparison in which 30% of.

  • 5

    Evidence and risk summary for off-label use

    This 2025 page is a consumer-facing evidence summary rather than a protocol. It states that no FDA-approved prescribing information exists, that the drug is available only off-label through compounding, and that any.

  • 6

    Research-vendor listing (format only)

    This is a vendor page, not a protocol. The capsule strength matches the lower trial dose, and the published certificates show lot-to-lot content ranging from about 5% under to 18% over label, which matters for anyone.

What the current evidence can support

Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.

  • Human

    Human studies and registrations

    3 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.

  • Not graded

    Community-reported use

    2 rows record what blogs, vendor write-ups or forums describe for Enclomiphene Citrate. None has been verified against primary literature.

Chemistry identifiers

Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.

Also listed as

trans-Clomiphene citrate, (E)-Clomiphene citrate, Androxal, Enclomid, Clomiphene B citrate, Enclomiphene citrate (USAN), UNII J303A6U9Y6, MFCD00058322

InChIKey

PYTMYKVIJXPNBD-BTKVJIOYSA-N

IUPAC name

2-[4-[(E)-2-chloro-1,2-diphenylethenyl]phenoxy]-N,N-diethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid

Limitations and unknowns

Important limitations

  • Every amount on this page is a report of what a source describes, not a protocol to follow.
  • Preclinical and community rows do not establish a human amount, schedule or route.
  • Formulation, purity and presentation vary by supplier and are not covered by the dossier.

Sources

6 curated references, each with its journal, year and study model, plus 2 community resources reported but not linked.

  1. Enclomiphene Citrate (PubChem CID 6420009)PubChem, National Library of Medicine2026Not graded
  2. Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and PharmacokineticsBJU International (PubMed)2013Human
  3. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosteroneFertility and Sterility (PubMed)2014Human
  4. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacementBJU International (PubMed)2016Human
  5. British Society of Sexual Medicine: Position Statement for the Potential Use of Enclomiphene in the Treatment of Male HypogonadismWorld Journal of Men's Health2026Human
  6. Repros Therapeutics Receives Complete Response Letter From FDA for EnclomipheneU.S. Securities and Exchange Commission (Repros Therapeutics press release)2015Human