Small Molecule — Selective Estrogen Receptor Modulator (SERM)
Clomiphene
FDA ApprovedClomiphene citrate · Clomid · Milophene · Serophene (discontinued) · clomifene (WADA’s spelling) · not a peptide: a small-molecule SERM
A pill approved since 1967 to help women ovulate. Men take it off-label so that their own testes make more testosterone, instead of taking testosterone itself.
- Molecular Weight
- 598.10 (citrate salt, per the label)
- Class
- Nonsteroidal SERM · a mixture of two isomers
- Isomers
- 30–50% zuclomiphene (cis); the rest enclomiphene (trans)
- Half-life
- 5–7 days (AUA table)
Zuclomiphene detectable > 1 month (label) - Route
- Oral tablet, 50 mg
- FDA Status
- Approved for ovulation in women · off-label in men
- Pipeline
- Phase 2 in men with low sex hormones having rotator cuff repair (University of Utah) (NCT04944836), primary completion est. Jul 2028; Phase 4 in subfertile men, clomiphene vs gonadotropins (Szeged University; enrolling by invitation) (NCT07523022), primary completion est. Sep 2026
- Published Studies
- 7,685 PubMed records; 231 on hypogonadism
- Human Studies
- Label trials, 7,578 patients · RCTs in men, 17 to 282 men each
- WADA Status
- Prohibited at all times (S4.2)
- Evidence Strength
- Ovulation: on the label
Men: RCTs of 2–3 months; clinic series - Cost & Access
- Prescription (Clomid, Milophene, generics)
What does it do? It blocks estrogen’s feedback on the hypothalamus and pituitary, and the pituitary releases more LH and FSH (Mulhall et al., 2018). In women that drives ovulation (Clomid label); in men the testes make more testosterone. In 12 healthy men, 50 mg a day for 30 days raised mean testosterone 146% (Miller et al., 2019).
Who uses it? Women with ovulatory dysfunction, on prescription: the approved use. Men with low testosterone, off-label, often because they want to keep their fertility; the published series come mostly from urology and fertility clinics. And anabolic-steroid users coming off a cycle, as “post-cycle therapy” (Grant et al., 2023), who in one forum study obtained such drugs mainly through the internet (Rochoy et al., 2022).
Does the evidence hold up? For ovulation, yes: the label rests on trials in 7,578 patients, and later trials compared it with metformin and letrozole. In men, randomized trials show testosterone, LH and FSH rising, but they enrolled 17 to 282 men for 2 to 3 months, symptom results are mixed, and the label says no adequate, well-controlled study shows it works for male infertility.
Bottom line? An approved women’s drug with short-term testosterone data in men from several randomized trials. What the trials don’t show: long-term outcomes in men, and what months of zuclomiphene build-up do.
Dosing from the Literature
Published for low testosterone: 25 or 50 mg by mouth, daily, every other day or three days a week, in men’s trials and clinic series; the AUA guideline’s table lists 25–50 mg every 1–2 days. Not published: an FDA-approved dose for men; the label’s 50–100 mg a day for 5 days is for ovulation.
The only approved dose is the label’s, for ovulation in women. For men, the table records the doses that trials and clinic series used and the regimen in the American Urological Association (AUA) guideline’s table, as each document gives them, with one forum analysis of what steroid users reported taking. None of them is a recommendation.
| Source | Amount | Frequency | Duration | Population | Notes |
|---|---|---|---|---|---|
| Clomid label (label dose) | 50 mg; 100 mg in a second course if no ovulation | Once daily | 5 days per course, started on or about day 5 of the cycle, or at any time with no recent uterine bleeding | Women with ovulatory dysfunction desiring pregnancy | “Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.” No further treatment after three courses without ovulation; long-term cyclic therapy not beyond about six cycles. |
| AUA guideline, Table 6 (stated regimen) | 25–50 mg | Every 1–2 days | Not stated | Men with testosterone deficiency | Marked “Not FDA-approved for use in males.” |
| Helo et al., 2015 (trial dose) | 25 mg | Daily | 12 weeks | 26 hypogonadal infertile men | Randomized, double-blind, against anastrozole 1 mg a day. |
| Pelusi et al., 2017 (trial dose) | 25 mg | Daily | 3 months, then crossover | 24 obese men with low testosterone, on metformin 2 g a day | Randomized, double-blind, placebo-controlled crossover. |
| Soares et al., 2018 (trial dose) | 50 mg | Daily (registry record NCT02380755) | 12 weeks | 78 obese men, total testosterone ≤ 300 ng/dL | Randomized, double-blind, placebo-controlled. |
| Habous et al., 2018 (trial dose) | 50 mg | Not stated in the abstract | 3 months | 282 men with hypogonadism wishing to preserve fertility | Three randomized arms: clomiphene, hCG 5,000 IU twice weekly, or both. |
| Miller et al., 2019 (trial dose) | 50 mg | Once daily | 30 days | 12 healthy men aged 25 to 38 | Open-label anti-doping study. |
| Katz et al., 2012 (clinic series) | 25 mg, titrated to 50 mg | Every other day | Mean 19 months | 86 men with hypogonadism, mean age 29 | The target testosterone was 550 ± 50 ng/dL; at the last visit 70% were on 25 mg every other day. |
| Mogar et al., 2025 (clinic series) | 50 mg | 3 days a week | At least 3 months | 20 men with hypogonadism, aged 27 to 76 | A study of IGF-1 levels on treatment. |
| İbis et al., 2026 (clinic series) | 25 mg | Daily | Not stated in the abstract | 79 men after 6 months or less of anabolic steroid use | Given alone or with hCG 1,500 IU three times weekly. |
| Rochoy et al., 2022 (forum analysis, self-reported) | Mean 69 mg | A day | Median 22 days (all SERMs) | Steroid users posting on a French bodybuilding forum, 2013–2019 | Reported use, not a study dose; the drugs were obtained mainly through the internet. |
No dose of clomiphene is FDA-approved for men. The rows above record the label’s dose for ovulation, one guideline table, trial doses, clinic regimens and self-reported use, as each document gives them; they are not a dosing guide. Any dose for any person is a decision for a licensed healthcare provider.
What It Is
Clomiphene citrate is an oral, nonsteroidal drug that its label calls an “ovulatory stimulant.” The label’s one indication is “the treatment of ovulatory dysfunction in women desiring pregnancy,” starting at 50 mg a day for five days per course (Clomid label). Drugs@FDA records the first application, Clomid (NDA 016131), as approved on February 1, 1967. It is not a peptide.
It is two molecules in one tablet. The label: “Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer.” The label adds that “Some data suggest that zuclomiphene has greater estrogenic activity than enclomiphene,” and that zuclomiphene stays in the body longer: after single doses in normal volunteers, “Detectable levels of zuclomiphene persisted for longer than a month in these subjects.” Each isomer has its own page here: Enclomiphene and Zuclomiphene.
Men use it off-label. Clomiphene blocks estrogen’s feedback on the hypothalamus and pituitary, LH rises, and the testes make more of their own testosterone, which is why urologists use it as an alternative to testosterone therapy in men who want to keep their fertility (Mulhall et al., 2018; Katz et al., 2012). The AUA guideline’s table marks it “Not FDA-approved for use in males.” The label itself says: “There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene.” It adds that the cause and effect relationship for the tumors “is not known.”
Where it stands in 2026: Sanofi’s original Clomid application is gone. FDA withdrew its approval at the company’s request as of July 3, 2024, after determining in 2021 that the product had not been withdrawn from sale for reasons of safety or effectiveness (Federal Register, 2021 and 2024). The Clomid brand is still sold, under a generic application (ANDA 075528, Cosette), alongside Milophene and five generic versions approved from November 2024 to May 2026 (Drugs@FDA).
Mechanism of Action
The label and the AUA guideline describe the mechanism; the measurements come from the studies named.
- Estrogen receptors in the hypothalamus and pituitary — The label: clomiphene “is capable of interacting with estrogen-receptor-containing tissues, including the hypothalamus, pituitary, ovary, endometrium, vagina, and cervix. It may compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptors.” The AUA guideline: SERMs “inhibit the negative feedback of E2 on LH production at the level of the hypothalamus and pituitary gland” (Mulhall et al., 2018).
- LH and FSH rise — “The first endocrine event in response to a course of clomiphene therapy is an increase in the release of pituitary gonadotropins” (Clomid label). In women, the ovarian follicle grows, and “Ovulation most often occurs from 5 to 10 days after a course of clomiphene citrate” (Clomid label). In 12 healthy men taking 50 mg a day for 30 days, mean LH rose 177% and FSH 170% (Miller et al., 2019).
- Testosterone from the testes — In the same 12 men, mean testosterone rose 146% (Miller et al., 2019). Age matters: seven days of clomiphene raised mean total testosterone 100% in young men but 32% in men aged 65 to 84, with similar LH responses; the authors place the difference in the testes (Tenover et al., 1987). In 292 men, a higher starting LH predicted a weaker response (Kim et al., 2026), and the AUA guideline reads low testosterone with high LH on a SERM as a sign that “the patient likely has testicular dysfunction.”
- Estradiol rises too — Estradiol went up on clomiphene in randomized trials (Helo et al., 2015; Soares et al., 2018) and in a 400-man series (Krzastek et al., 2019). In 15 men on long-term treatment, median estradiol went from 17.0 to 34.0 pg/mL (Helo et al., 2017).
- Two isomers, different fates — The label: “The two clomiphene isomers have been found to have mixed estrogenic and antiestrogenic effects, which may vary from one species to another.” After one 50 mg dose in 24 women, the Z (cis) isomer was eliminated much more slowly than the E (trans) isomer, with significant plasma levels up to a month later (Mikkelson et al., 1986). In 15 men taking 25 mg a day for a median 25.9 months, median serum zuclomiphene was 44.0 ng/mL and enclomiphene 2.2 ng/mL, a ratio of 20 to 1 (Helo et al., 2017).
- The isomers in male mice — In a chronic dosing study by Repros Therapeutics scientists, zuclomiphene given alone was associated with “profound effects on Leydig cells, epididymis, seminal vesicles, and kidneys,” while enclomiphene alone had “positive effects on testosterone production and no effects on testicular histology.” The authors conclude that this justifies developing enclomiphene “for clinical use in human males” (Fontenot et al., 2016). This is animal work, by a company whose authors argue for enclomiphene.
- Liver metabolism (CYP2D6) — Clomiphene “is metabolized into its 4-hydroxylated active metabolites, primarily by CYP2D6.” In 22 Korean volunteers given one 50 mg dose, exposure to the active moiety was 2.95 times higher in people with two copies of CYP2D6*10, the most common variant allele in Asians, than in those with none (Kim et al., 2018).
What the Research Shows
Below: the approved use first, then the off-label use in men, grouped by the kind of evidence.
- Ovulation in women (the approved use) — In the label’s clinical investigations, 7,578 patients received clomiphene and about 30% became pregnant; 7.98% of the reported pregnancies were multiple (Clomid label). In 626 women with polycystic ovary syndrome, live births were 22.5% on clomiphene, 7.2% on metformin and 26.8% on both (Legro et al., 2007). In 750 women with the syndrome, letrozole gave more live births than clomiphene, 27.5% vs 19.1% (Legro et al., 2014).
- Testosterone in men: randomized trials — In 17 men with erectile dysfunction and secondary hypogonadism, two months of clomiphene raised LH, FSH and total and free testosterone over placebo, but sexual function did not improve “except for some limited parameters in younger and healthier men” (Guay et al., 1995). In 24 obese men on metformin (21 evaluable), testosterone rose from 3.03 to 5.99 ng/mL over 3 months on 25 mg a day, and not significantly on placebo (Pelusi et al., 2017). In 78 obese men, 50 mg for 12 weeks raised total and free testosterone, estradiol, LH, FSH and SHBG, improved one sexual complaint (weaker erections) and lean mass, and lowered HDL cholesterol (Soares et al., 2018). In 26 hypogonadal infertile men, testosterone rose more on clomiphene 25 mg a day than on anastrozole, with no change in semen or questionnaire scores in either group (Helo et al., 2015). In 282 men, clomiphene, hCG and the two together raised testosterone with no significant difference between groups, from a mean 2.31 to 5.17 nmol/L; symptom scores improved most on the combination (Habous et al., 2018).
- Testosterone in men: clinic series — In 86 men with a mean age of 29, treated for a mean 19 months, mean testosterone and gonadotropins rose and no major side effects were recorded (Katz et al., 2012). In 46 men treated for more than a year, testosterone went from 228 ng/dL at baseline to 612, 562 and 582 ng/dL at 1, 2 and 3 years, and bone density scores improved (Moskovic et al., 2012). Of 120 men treated for more than 3 years at two institutions, 88% reached normal testosterone, 77% reported better symptoms and 8% reported side effects (Krzastek et al., 2019). In 292 men with a median age of 60, 47% met the study’s definition of response within 12 weeks (Kim et al., 2026). In a chart review, 65 men on 50 mg every other day averaged 573 ng/dL on treatment, against 553 ng/dL for 39 men on testosterone gel (Taylor & Levine, 2010). In an age-matched comparison, men on clomiphene reported satisfaction similar to men on testosterone injections or gels, and lower libido than men on injections (Ramasamy et al., 2014). In 54 men in Japan taking 50 mg every other day for up to a year, testosterone stayed raised and aging-symptom scores appeared to decline, but the sexual dysfunction score did not improve significantly (Anno et al., 2026).
- Pooled analyses — Nineteen studies (four randomized, fifteen observational; 1,642 patients): testosterone, free testosterone, LH, FSH, SHBG and estradiol rose, side effects were reported in less than 10% of study populations and no serious adverse events were reported (Huijben et al., 2022). Ten randomized trials of clomiphene or enclomiphene (819 men): total testosterone rose 273.76 ng/dL more than on placebo, with no significant difference from testosterone gel (Hohl et al., 2025). Eleven studies comparing clomiphene with testosterone therapy (1,512 men): no significant difference in testosterone overall, higher levels on injectable testosterone in one study, and lower libido scores on clomiphene in three studies (Constantinou et al., 2026).
- Male infertility — A meta-analysis of 11 randomized trials of clomiphene or tamoxifen in idiopathic male infertility found a higher pregnancy rate than controls, odds ratio 2.42 (95% CI 1.47–3.94) (Chua et al., 2013). The label’s position is the one quoted above: no adequate or well-controlled studies demonstrate effectiveness in male infertility. In some men, sperm counts fall on clomiphene (see Side Effects).
- Healthy men, and doping — In 12 healthy men representing a recreational-athlete population, 50 mg a day for 30 days raised mean testosterone 146%, LH 177% and FSH 170%; the authors conclude it “can be abused as a performance-enhancing drug” (Miller et al., 2019).
- After anabolic steroids — In a retrospective series of 79 men who had used steroids for 6 months or less, hormone levels normalized in all groups by month 6; normal semen at 12 months was recorded in 87.5% on clomiphene plus hCG, 69.2% on clomiphene alone and 58.6% with no treatment (İbis et al., 2026). In a survey of 470 men who use steroids, 56.5% of those who had tried to stop had used post-cycle therapy (Grant et al., 2023).
Every study in men is of an off-label use. The randomized trials enrolled 17 to 282 men for 2 to 3 months; the longer data come from clinic series, most of them retrospective. Testosterone rose on average in each trial and series above, though only 47% of men in one series met its definition of response (Kim et al., 2026), while symptom and sexual-function results are mixed. The authors of the 2026 meta-analysis call their findings preliminary and ask for large randomized trials with clinical and fertility endpoints (Constantinou et al., 2026).
Human Data
Human data on clomiphene come in three groups: the label’s trials in women, the trials and clinic series in men above, and studies of how the two isomers behave in the body.
- Label trials (women) — 7,578 patients received clomiphene in the clinical investigations behind the label; its adverse-event table covers 8,029 (Clomid label). The two Legro trials are registered as NCT00068861 and NCT00719186.
- Registered trials in men, completed — NCT02380755 (University of São Paulo; 78 men; 50 mg a day or placebo for 12 weeks; completed January 2017; the same size, design and institution as the Soares trial). NCT03933618 (Albany Medical College; 24 men; crossover against anastrozole and placebo; completed March 2017; results posted). NCT01880086 (Weill Cornell; 13 men with low testosterone on long-term opioids; completed November 2017; results posted). NCT01904734 (Phoenix VA; 42 men, with and without prior testosterone treatment; completed October 2018). NCT00697814 (Federal University of São Paulo; 15 men with prolactinomas; 50 mg a day for 12 weeks; completed June 2005).
- Registered trials in men, open — NCT04944836 (University of Utah; Phase 2; 58 men aged 40 to 80 with low sex hormone levels planned; clomiphene 50 mg every other day or placebo for seven months around rotator cuff surgery; recruiting; estimated primary completion July 2028). NCT07523022 (Szeged University; Phase 4; 500 subfertile men planned; clomiphene 50 mg a day or gonadotropins for 12 weeks; enrolling by invitation; estimated primary completion September 2026).
- A planned steroid-recovery pilot — CloTASH, in Oslo: open-label and non-randomized, 16 weeks of clomiphene with testosterone gel for the first four weeks and optional hCG from week 4, in men with steroid dependence who intend to stop (Havnes et al., 2024). The documents read for this page include the protocol, not results.
- Isomer pharmacology — Single-dose kinetics in 24 women (Mikkelson et al., 1986), serum isomer levels in 15 men on long-term treatment (Helo et al., 2017), CYP2D6 genotype in 22 volunteers (Kim et al., 2018), and urinary detection in 12 men (Miller et al., 2019), all described above.
The evidence meter on the clomiphene card reads “Approved drug” because the Hormones & libido group counts an approved therapy on the hormone axis. That approval covers ovulation in women. In men, the evidence is the off-label trials and series above.
Reconstitution & Storage
Clomiphene is an oral tablet. There is nothing to reconstitute and nothing to inject. The table gives the tablet as its label describes it.
| Form | Strength | Storage (label) | Notes |
|---|---|---|---|
| Clomid tablet (Cosette) | 50 mg | Controlled room temperature, 15° to 30°C (59° to 86°F), protected from heat, light and excessive humidity, in closed containers | Round, off-white, debossed “Par 701” with a bisect on one side; cartons of 10 and 30. |
- Generic tablets — Each generic carries its own label; the storage above is the Clomid label’s.
- Other forms — None of the documents read for this page gives storage or stability data for compounded capsules or for products sold online.
Side Effects & Risks
Side effects come from the label (mostly women taking it for ovulation), from studies in men, and from reports; numbers are as each source gives them.
- Vision — Visual symptoms in 1.5% of patients in the label’s clinical studies; after approval, reports of “temporary or prolonged loss of vision, possibly irreversible” (Clomid label). In men treated for more than 3 years, 3 of 120 reported blurred vision (Krzastek et al., 2019).
- Mood — Post-approval reports of anxiety, irritability, mood changes and psychosis (Clomid label). In men: mood changes in 5 of 120 (Krzastek et al., 2019) and anxiety or irritability in 5 of 51 on clomiphene with anastrozole (Alder et al., 2018). At one academic center, in men switched from clomiphene to enclomiphene, decreased libido, reduced energy and mood changes were documented less often on enclomiphene (Saffati et al., 2024).
- Breasts and estradiol — Gynecomastia has been reported in men (Clomid label); breast tenderness in 2 of 120 men (Krzastek et al., 2019). Estradiol rises on treatment (see Mechanism).
- Libido — Pooled across three studies (199 men), libido scores were lower on clomiphene than on testosterone therapy (Constantinou et al., 2026); decreased libido in 4 of 51 men on clomiphene with anastrozole (Alder et al., 2018).
- Sperm counts can fall — Across 11 studies reporting adverse effects on semen (384 men), 19%, 21%, 17% and 24% of men had a fall in sperm count, concentration, motility and total motile count, and in up to 17% the fall did not recover after stopping (Gundewar et al., 2021).
- Cholesterol and triglycerides — HDL cholesterol fell in the 78-man trial (Soares et al., 2018). The label reports cases of high triglycerides, some with pancreatitis, with higher risk in people with a personal or family history of hyperlipidemia and with higher-than-recommended doses or longer treatment.
- IGF-1 — In 20 men on clomiphene, IGF-1 fell in 15, and in 2 it fell to more than 2 standard deviations below the age- and sex-matched mean (Mogar et al., 2025).
- Blood clots — Post-approval reports include pulmonary embolism, phlebitis and thrombophlebitis; in women with severe ovarian hyperstimulation, “Death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred” (Clomid label).
- Liver — Contraindicated in liver disease or a history of liver dysfunction; post-approval reports of raised transaminases and hepatitis (Clomid label).
- Testicular tumors — Reported in men using clomiphene; the label says the cause and effect relationship “is not known.”
- Red blood cells — In a retrospective comparison, polycythemia was recorded in 1.7% of 188 men on clomiphene and 11.2% of 175 on testosterone (Wheeler et al., 2017); hematocrit above 54% in 2 of 51 men on clomiphene with anastrozole (Alder et al., 2018).
- Compared with testosterone in records — In US veterans’ records (2,518 propensity-matched patients per group), new hypertension, stroke, coronary artery disease, polycythemia and osteoporosis, and all-cause mortality (1.83% vs 10.13%), were all recorded less often after clomiphene than after testosterone (Tadisina et al., 2026). It is a records study, not a trial.
- Women — Ovarian enlargement in 13.6% and hot flushes in 10.4% of patients in the label’s studies; ovarian hyperstimulation syndrome, which “may progress rapidly”; multiple pregnancy; contraindicated in pregnancy; and “Prolonged use of clomiphene citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor” (Clomid label).
- Drug interactions — “Drug interactions with clomiphene citrate have not been documented” (Clomid label). CYP2D6 genotype changed exposure to its active metabolites in one study (Kim et al., 2018).
- WADA prohibited — Clomifene is prohibited at all times under S4.2 of the 2026 List. After 30 days of use, zuclomiphene was detectable in urine for 121 to more than 261 days (Miller et al., 2019).
- Identity and purity — Pharmacy tablets are FDA-approved products. Steroid users in the forum study obtained their SERMs mainly through the internet (Rochoy et al., 2022); no analysis of such products is among the documents read for this page.
Bloodwork & Monitoring
What the label and the AUA guideline say about testing, and what the studies measured:
- Testosterone — The AUA panel recommends testing no sooner than four weeks after starting clomiphene, anastrozole or hCG, then every 6–12 months once stable, and notes “anecdotal concerns about clomiphene citrate-associated tachyphylaxis” (Mulhall et al., 2018).
- LH — The AUA table lists LH four weeks after starting a SERM in men whose testosterone stays low, and in men on a SERM who stop responding. With low testosterone and low or normal LH, the guideline suggests considering a higher SERM dose; with low testosterone and high LH, it reads the problem as likely testicular (Mulhall et al., 2018).
- Estradiol — Optional in all men on SERMs, in the AUA table. In one clinic, anastrozole was added when estradiol went above 50 pg/mL or the testosterone-to-estradiol ratio fell below 10 (Alder et al., 2018).
- Hematocrit — The AUA table lists a baseline level, to confirm it is below 50% before treatment.
- Triglycerides — The label recommends a triglyceride test before starting, and periodic tests in people with a personal or family history of hyperlipidemia.
- IGF-1 — The authors of the IGF-1 study recommend interval checks of IGF-1 and of symptoms of growth hormone deficiency in men on clomiphene (Mogar et al., 2025).
- Semen — The falls in sperm count above were found in studies that measured semen parameters (Gundewar et al., 2021).
- Eyes — The label: any visual symptom means stopping treatment and a complete eye examination.
- Women (label) — A pelvic examination before each course, and checks for pregnancy, ovarian enlargement and ovarian cysts between courses.
- Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.
Commonly Stacked With
Combinations a study tested or a document shows people use, recorded as documented. None is a recommendation.
In a 282-man randomized trial, clomiphene 50 mg plus hCG 5,000 IU twice weekly raised testosterone as much as either alone and improved symptom scores the most (Habous et al., 2018). After steroid cycles, 25 mg a day plus hCG 1,500 IU three times weekly was followed by the highest rate of normal semen at 12 months in one retrospective series (İbis et al., 2026). In 19 men with hypogonadotropic hypogonadism, the pair for 12 months was followed by sperm in the semen of 47.4%, almost all of it deformed (Trinh et al., 2021). Steroid users’ self-administered post-cycle therapy “typically” involves hCG and SERMs (Grant et al., 2023).
An aromatase inhibitor (Mulhall et al., 2018). At one clinic it was added to clomiphene in 51 men whose estradiol went above 50 pg/mL or whose testosterone-to-estradiol ratio fell below 10; estradiol normalized, and 11 men had side effects (Alder et al., 2018). One randomized trial compared the two head to head (Helo et al., 2015).
Used with clomiphene in IVF and ICSI stimulation: clomiphene 100 mg a day plus hMG in 40 women (Hwang et al., 2003). In 189 couples, a clomiphene/hMG protocol with a GnRH antagonist gave fewer clinical pregnancies than a standard long protocol, 24% vs 59% (Mansour et al., 2003). The label reports ovarian hyperstimulation in some women who took clomiphene with gonadotropins; it also says there is no standard regimen for combining clomiphene with other ovulation-inducing drugs or for IVF, and does not recommend it for these uses.
Tested with clomiphene in 626 women with polycystic ovary syndrome: live births 26.8% on both vs 22.5% on clomiphene alone, not a significant difference (Legro et al., 2007). In a crossover trial in men, both arms took metformin (Pelusi et al., 2017).
Legal Status
FDA-approved, for women. Clomiphene citrate 50 mg tablets are approved for “ovulatory dysfunction in women desiring pregnancy” (Clomid label). Drugs@FDA lists seven prescription applications today: Clomid (ANDA 075528, Cosette), Milophene (ANDA 072196) and five generic ANDAs approved from November 2024 to May 2026. The original Clomid application, NDA 016131, approved February 1, 1967, was withdrawn at Sanofi’s request as of July 3, 2024; FDA had determined in 2021 that it was not withdrawn from sale for reasons of safety or effectiveness (Federal Register, 2021 and 2024). Serophene (NDA 018361, approved March 22, 1982) is listed as discontinued.
Off-label in men. The AUA guideline’s table marks clomiphene “Not FDA-approved for use in males.” The guideline says clinicians “may use aromatase inhibitors, human chorionic gonadotropin, selective estrogen receptor modulators, or a combination thereof in men with testosterone deficiency desiring to maintain fertility,” a Conditional Recommendation with Grade C evidence (Mulhall et al., 2018).
Compounding. Clomiphene is not on FDA’s 503A bulk drug substances categories list (updated May 14, 2026), the list of nominated substances; its trans isomer, enclomiphene citrate, is in Category 1 of that list. Section 503A lets pharmacies compound with bulk substances that comply with a USP monograph, if one exists, or, if none exists, that are components of FDA-approved drugs or on FDA’s bulks list (21 U.S.C. 353a(b)(1)(A)(i)); the label’s ingredient is “clomiphene citrate USP.”
WADA prohibits clomifene at all times under S4.2, anti-estrogenic substances (anti-estrogens and SERMs), a class of Specified Substances (Prohibited List 2026).
ClinicalTrials.gov lists two recruiting or enrolling trials that test clomiphene in men, NCT04944836 and NCT07523022, and trials in women (searched September 29, 2026).
A prescription drug (“Rx Only” on the label), sold as 50 mg tablets by the companies holding the applications above; DailyMed lists 15 clomiphene tablet labels from makers, distributors and repackagers (read September 29, 2026). For men, it is prescribed off-label; the studies above come from urology, fertility and endocrinology clinics. Steroid users in the forum study obtained SERMs mainly through the internet (Rochoy et al., 2022).
Pricing and availability vary and are set by the seller. Kalios does not sell compounds.
Next Steps
References
- Clomid (clomiphene citrate tablets, USP) prescribing information. Cosette Pharmaceuticals, Inc. Revised 08/2023. DailyMed set ID 2ca373c1-4dba-4126-8616-5c533d606fe5 (version published February 3, 2025). dailymed.nlm.nih.gov. Read September 29, 2026.
- FDA. Drugs@FDA data for clomiphene citrate, via openFDA (api.fda.gov/drug/drugsfda.json). Read September 29, 2026: NDA 016131 (Clomid; original approval February 1, 1967; discontinued), NDA 018361 (Serophene; approved March 22, 1982; discontinued), ANDA 075528 (Clomid, Cosette), ANDA 072196 (Milophene), and ANDAs 216545, 216739, 219406, 219781 and 220673 (generic tablets, approved November 2024 to May 2026).
- FDA. Determination That Folic Acid, Oral Tablets, 1 Milligram, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register, 86 FR 15682, March 24, 2021 (FR Doc. 2021-06059; lists NDA 016131, Clomid). federalregister.gov.
- FDA. Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications. Federal Register, 89 FR 47566, June 3, 2024 (FR Doc. 2024-12065; NDA 016131, Clomid; approval withdrawn as of July 3, 2024). federalregister.gov.
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Last updated: September 29, 2026 | Profile authored by Kalios Peptides research team