Here's the short version. If keeping your fertility is the goal, enclomiphene is the option people ask about, but it isn't FDA-approved and its evidence is thin. If you want the approved route with larger trials behind it, that's testosterone therapy. Several online programs sell both, including Strut Health, Maximus and PeterMD.
Enclomiphene and TRT side by side
| Enclomiphene | TRT (testosterone) | |
|---|---|---|
| How it works | Blocks estrogen's signal at the brain, so the pituitary releases more LH and FSH and the testes make more testosterone | Supplies testosterone from outside the body |
| FDA status | Never approved. Compounded under FDA's interim policy (503A Category 1 on FDA's May 2026 list) [1] | FDA-approved for men with low testosterone from a diagnosed cause [6] |
| FDA advisers | Voted 4 to 8 against listing it for compounding (June 8, 2022) [2] | No comparable vote |
| Testosterone effect | Similar to testosterone gel in a 2025 meta-analysis [11] | Raises testosterone directly |
| Sperm production | Kept in the normal range in trials [10] | Can be suppressed; gel cut sperm counts in head-to-head trials [5] [10] |
| Largest safety trial | Two 16-week phase III trials, about 240 men enrolled | TRAVERSE: 5,246 men, about 33 months [7] |
| Forms online | Oral capsule | Injection, cream or gel, oral capsule |
| Controlled substance | No | Yes, Schedule III |
| Monthly cost online | $55–$229 | $59–$199.99 (injections) |
| Labs | Required by some programs (Maximus: before you start, then at 1 and 3 months) | Lab-based at Maximus, PeterMD and DudeMeds |
How each one works
Enclomiphene makes your body produce more testosterone; TRT gives you testosterone directly. That one difference drives almost everything else on this page.
Enclomiphene is a selective estrogen receptor modulator. It's one of the two isomers that make up clomiphene, the fertility pill sold as Clomid. Clomid's label describes it as a mix of zuclomiphene and enclomiphene [4]. Clomid is approved for ovulation problems in women, not for men, and that approval doesn't cover enclomiphene on its own.
By blocking estrogen feedback at the brain, enclomiphene raises the two pituitary hormones, LH and FSH, that tell the testes to make testosterone and sperm. TRT works the other way around. Outside testosterone tells the brain there's plenty, so LH and FSH fall. The AndroGel label warns that with large doses, sperm production may be suppressed through that feedback [5].
What the trials show
Enclomiphene raised testosterone about as much as testosterone gel in small trials, and it kept sperm counts up while gel didn't. Here's the record.
| Study | Design | Finding |
|---|---|---|
| Kaminetsky 2013 [8] | Phase IIB, 12 men previously on testosterone gel, open-label | Sperm counts rose in 7 of 7 men on enclomiphene at 3 months. Gel didn't lift any of the five men above 20 million per mL at 3 months. Testosterone fell back a month after stopping |
| Wiehle 2014 [9] | Phase II, randomized vs 1% testosterone gel | Testosterone, estradiol and LH rose similarly to gel; FSH and LH rose on enclomiphene; sperm counts were conserved |
| Kim 2016 [10] | Two phase III trials, 16 weeks, double-blind, vs AndroGel 1.62% and placebo, in overweight men 18 to 60 | Testosterone rose in all treatment groups. LH and FSH rose on enclomiphene and fell on gel. Sperm stayed normal on enclomiphene, with a marked drop on gel |
| Hohl 2025 [11] | Meta-analysis of 10 randomized trials, 819 men, clomiphene and enclomiphene pooled | Total testosterone up 273.76 ng/dL vs placebo. No significant testosterone difference vs gel; LH and FSH higher than on gel |
Kaminetsky, Wiehle and Kim were funded by, or run with staff of, Repros Therapeutics, enclomiphene's former developer. Hohl 2025 was a university meta-analysis and pools clomiphene with enclomiphene.
- Clomiphene or enclomiphene
- 273.76 ng/dL[11]
The big gap: symptoms. FDA's reviewer told its advisory committee in 2022 that the trials did not show clinically meaningful improvement in symptoms or signs of low testosterone [3]. A higher lab number isn't the same as feeling well, and enclomiphene hasn't shown the second part yet.
Fertility: the main reason men ask
If you want children soon, enclomiphene's trials point its way, and TRT's label points away from TRT. In the phase III trials, men on enclomiphene kept sperm concentration in the normal range, while men on testosterone gel had a marked reduction [10]. The AndroGel label carries a warning about possible effects on sperm count [5].
Two cautions. No trial here measured pregnancies, so "kept sperm counts normal" isn't a fertility promise. And these were short trials. Tell your prescriber about your family plans up front; it changes the conversation.
FDA status: why enclomiphene can be compounded but isn't approved
Enclomiphene has no FDA approval, but FDA lets licensed pharmacies compound it while it decides whether to add it to the permanent list. It sits in Category 1, "under evaluation", on FDA's 503A list updated May 14, 2026 [1]. FDA's reviewer said in 2022 that no FDA-approved drug contains enclomiphene [3].
| Date | What happened |
|---|---|
| 2015 | The developer, Repros, announced an FDA complete response saying its phase 3 design couldn't show clinical benefit, as FDA's reviewer recounted in 2022 [3] |
| 2018 | Europe's medicines agency refused marketing authorization, per FDA's reviewer [3] |
| June 8, 2022 | FDA's compounding advisory committee voted 4 yes, 8 no on listing it. Members voting no noted the lack of clinical efficacy evidence [2] |
| May 14, 2026 | Still in Category 1 on FDA's 503A list. No final decision published [1] |
What that means for you: today a pharmacy may legally compound it, but that could change if FDA makes a final call. Testosterone sits on firmer ground. It's FDA-approved for men with low testosterone from a diagnosed cause, and it's a Schedule III controlled substance [6].
Side effects: what's documented
TRT's risks are spelled out on its labels; enclomiphene's come from small trials and FDA's 2022 review. For enclomiphene, FDA listed concerns about heart and clotting events, higher estradiol, higher PSA and higher hematocrit, and said long-term safety data are lacking [3]. Non-serious effects reported in its studies included hot flushes, muscle spasms and headaches. Cataracts were seen in animal studies, and Europe's reviewers recommended eye monitoring [3].
For TRT, the TRAVERSE trial found heart events in 7.0% of men on testosterone gel vs 7.3% on placebo. Atrial fibrillation, acute kidney injury and blood clots in the lung were more common on testosterone [7]. Labels also flag blood pressure increases, high red blood cell counts, and worsening of an enlarged prostate. Testosterone gels carry a boxed warning about children exposed to the gel on your skin [5].
What each costs online
Enclomiphene runs $55–$229 a month across online programs, and testosterone injections run $59–$199.99. Maximus and PeterMD price both at the same monthly rate. Watch the billing period: some charge every two months or sell 12-week supplies.
| Provider | Enclomiphene | Plan structure | Also sells TRT? |
|---|---|---|---|
| Strut Health | From $80.10 | 30-day auto-refill; price rises with strength | Not listed |
| Maximus | $200 | Month to month; lower monthly rate on prepaid 3- and 12-month plans | Price at checkout |
| HealthRx | $206 | Monthly; lower on prepaid 3-, 6- and 12-month plans | Yes, $179 injections |
Also offered by (no standing monthly price published): PeterMD, RNK Health, DudeMeds. From each company's own pages [12] [13] [14] [15] [16] [17].
Lab fees can add more than the gap between the two drugs. Maximus requires labs before you start and at one and three months, at extra cost unless you bring your own [14]. PeterMD sells its blood panels separately [13]. The two programs are compared line by line in Maximus or PeterMD. Weighing testosterone forms? See testosterone injections or cream.
Who each one fits
- Enclomiphene fits men with low LH and FSH (secondary hypogonadism, the group the trials enrolled) who want to keep sperm production. It means accepting an unapproved, compounded drug with limited long-term data.
- TRT fits men with a diagnosed cause of low testosterone who want an FDA-approved drug with large safety trials, and who aren't planning children soon or have discussed fertility with their prescriber.
- Neither fits without labs. Both need a measured low testosterone and a prescriber who checks in over time.
Curious about other ways to raise testosterone? Sermorelin or testosterone covers the growth-hormone angle, and the hormones shortlist lists programs by goal. Not sure where to start? Take the 30-second match.