A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism [confirmed morning testosterone (T) ≤300 ng/dL] following a 6 month diet and 15 month exercise program.

Start Date11 Jan 2016

Sponsor / Collaborator

Repros Therapeutics, Inc.

NCT02274181

/ CompletedPhase 1

An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration

The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(
]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.

Start Date01 Dec 2014

Sponsor / Collaborator

Repros Therapeutics, Inc.

[+1]

NCT02160704

/ WithdrawnPhase 2/3IIT

PHASE 2b RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED EXPLORATORY STUDY TO EVALUATE THE EFFICACY OF ANDROXAL IN IDIOPATHIC MALE INFERTILITY (PROTOCOL #01-14-40-08)

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits.
The purpose of this study is to determine the effect the Androxal on sperm production.

Start Date22 Sep 2014

Sponsor / Collaborator

Baylor College of Medicine

100 Clinical Results associated with Enclomiphene citrate

100 Translational Medicine associated with Enclomiphene citrate

100 Patents (Medical) associated with Enclomiphene citrate

171

Literatures (Medical) associated with Enclomiphene citrate

01 Jan 2025·Archives of Endocrinology Metabolism

Clomiphene or enclomiphene citrate for the treatment of male hypogonadism: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Sande-Lee, Simone van de ; Hohl, Alexandre ; Ferreira, Rafael Oliva Morgado ; Pasqualotto, Eric ; Chavez, Matheus Pedrotti ; Ronsoni, Marcelo Fernando

OBJECTIVE:

This study aimed to evaluate the efficacy and safety of selective estrogen receptor modulators (SERMs), specifically clomiphene and enclomiphene, in treating men with functional hypogonadism.

MATERIALS AND METHODS:

A systematic search was conducted in PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials comparing SERMs with placebo, testosterone (T) gel, or human chorionic gonadotropin (hCG), up to July 2024. The primary endpoints were total testosterone (TT), follicle-stimulating hormone (FSH), and luteinizing hormone (LH). Weighted mean differences (MDs) and risk ratios (RRs) were calculated for continuous and binary endpoints, respectively, with 95% confidence intervals (CIs).

RESULTS:

SERM therapy significantly improved TT (MD: 273.76 ng/dL; 95% CI: 191.87-355.66 ng/dL; p < 0.01; I2 = 89%), LH (MD: 4.66 IU/L; 95% CI: 3.37-5.94 IU/L; p < 0.01; I2 = 55%), and FSH (MD: 4.59 IU/L; 95% CI: 2.88-6.30 IU/L; p < 0.01; I2 = 68%) compared to placebo. No significant difference in TT was observed between the SERM and T gel groups. TT levels were significantly higher with SERM therapy and the combined treatment of SERM and hCG compared to hCG alone (158 vs. 153 vs. 134 ng/dL, respectively; p < 0.002 for both comparisons).

CONCLUSION:

SERM therapy is associated with significantly improved levels of TT, LH, and FSH in hypogonadal men compared to placebo, and significantly enhanced levels of LH and FSH compared to T gel. The findings suggest that SERM therapy effectively increases TT levels in men with functional hypogonadism and should be considered as an alternative to T gel therapy.

01 Sep 2024·Translational Andrology and Urology

Safety and efficacy of enclomiphene and clomiphene for hypogonadal men

Article

Author: Saffati, Gal ; Kronstedt, Shane ; Hinojosa-Gonzalez, David E ; Lipshultz, Larry I. ; Orozco Rendon, Daniela ; Hinojosa-Gonzalez, David E. ; Kassab, Jordan ; Khera, Mohit ; Lipshultz, Larry I

Background:

Both clomiphene citrate and its isomer, enclomiphene, have become widespread within urologic practice; thus, understanding these medications' comparative benefits and risks is crucial for optimizing treatment and providing improved therapeutic options. We sought to investigate the longitudinal benefits and risks associated with enclomiphene, compared to clomiphene, and to provide valuable insights for clinicians when making treatment decisions in the management of hypogonadism.

Methods:

We retrospectively studied patients at our academic center who had been prescribed clomiphene and, later, enclomiphene for hypogonadism. Baseline laboratory values were documented for each patient before being prescribed clomiphene, followed by subsequent values for each variable in the most recent visit before stopping clomiphene and any noted adverse effects experienced during this time. The same process was repeated for enclomiphene, using the clomiphene levels as an updated baseline. Two-tailed t-tests were employed using R to analyze the longitudinal impacts of clomiphene and enclomiphene on serum hormone values as well as a regression analysis to estimate the odds ratio (OR) for adverse events between the two therapies.

Results:

Among 66 patients, enclomiphene exhibited a median testosterone increase of 166 (vs. 98 ng/dL, P=0.20) with lower estradiol change than clomiphene (-5.92 vs. 17.50 pg/mL, P=0.001). Adverse effects were statistically significantly less frequent with enclomiphene, including decreased libido (P=0.001), reduced energy (P=0.044), and mood changes (P=0.03). Regression analysis confirmed lower odds of adverse events with enclomiphene [OR: 0.18; 95% confidence interval (CI): 0.07-0.44, P=0.02].

Conclusions:

Our findings demonstrate that enclomiphene provides improvement in testosterone levels with a lower rate of documented adverse events. These findings support enclomiphene as a comparable treatment option for hypogonadal men while minimizing the risk of adverse effects. Further research and more extensive studies are warranted to validate these conclusions and explore the additional long-term effects of enclomiphene to guide future patient counseling regarding these medications.

01 Nov 2023·Plastic surgery (Oakville, Ont.)

Clomiphene Citrate and Enclomiphene Hydrochloride Exposure Is Associated With Interfrontal Suture Fusion in Zebrafish

Article

Author: Bezuhly, Michael ; Franz-Odendaal, Tamara A.

Background: The last several decades have witnessed an increase in metopic craniosynostosis incidence. Population-based studies suggest that pharmacological exposure in utero may be responsible. This study examined effects of the fertility drug clomiphene citrate (CC) on calvarial development in an established model for craniofacial development, the zebrafish Danio rerio. Results: Zebrafish larvae were exposed to clomiphene citrate or its isomer enclomiphene for five days at key points during calvarial development. Larvae were then raised to adulthood in normal rearing water. Zebrafish were analyzed using whole-mount skeletal staining. We observed differential effects on survivability, growth and suture formation depending on the treatment. Treatments with CC or enclomiphene at 5.5 mm SL led to increased fusion of the interfrontal suture (p < .01) compared to controls. Conclusions: Exposure to fertility drugs appears to affect development of the cranial vault, specifically the interfrontal suture, in zebrafish. Further research is required to identify the signaling mechanisms at play. This work suggests that fertility drug treatment may contribute to the increased incidence of metopic craniosynostosis observed globally.

News (Medical) associated with Enclomiphene citrate

10 Sep 2025

·endpoints.news

Hims expands into hormone health with men's testosterone treatment

Hims & Hers is launching men’s hormone health services, the company said Wednesday. To start, Hims will offer compounded enclomiphene, a treatment used to help men with low testosterone by inhibiting estrogen production. Next year, it plans to offer injectable and oral testosterone. It’s exclusively working with Marius Pharmaceuticals, which makes the oral testosterone medication Kyzatrex, to offer a Hims-labeled oral testosterone. With the launch of testosterone treatments, Hims joins a growing group of telehealth companies, including Hone Health, Henry Meds and independent clinics that have been prescribing testosterone online over the past few years. During Hims’ second-quarter earnings call, CEO Andrew Dudum highlighted hormonal health as one of the ways in which the company plans to grow its business to $6.5 billion in revenue by 2030, along with lab testing and international expansion. The new offering is the first time at-home lab testing is included in the launch of a new specialty. “The interrelationships between sexual health, obesity, low testosterone, are really profound, and we’re marching towards really holistic care that is comprehensive,” Peter Stahl, head of men’s health at Hims told Endpoints News. “Adding testosterone into our portfolio improves our ability to address some of the other really important conditions that we currently treat.” The expansion in 2026 into offering testosterone will also mark the first time Hims will offer a controlled substance. It’s listed as a schedule III drug by the government, meaning its distribution is limited because of the risk of abuse. “We’ve systematically built up a clinical quality and safety program over many years that I think is robust enough to support safe, effective and evidence-based controlled substance prescribing now,” Stahl said. Because it’s a controlled substance, it can often be hard to get prescribed testosterone during a traditional doctor’s office visit, he said. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here .)

10 Sep 2025

·firstwordpharma.com

Hims & Hers Health expands into testosterone therapy after Novo Nordisk breakup

Telehealth company Hims & Hers Health announced Wednesday that it is launching treatment for low testosterone. Effective immediately, providers on the Hims platform can prescribe personalised doses of a compounded version of the selective estrogen receptor modulator enclomiphene, either alone or combined with the erectile dysfunction medication tadalafil, for men experiencing sexual symptoms. Beginning next year, Hims will also offer Kyzatrex (testosterone undecanoate), an FDA-approved oral testosterone replacement therapy from Marius Pharmaceuticals.According to Hims, an estimated 20 million men in the US have low testosterone — a condition associated with fatigue, depression, reduced libido and an increased risk of serious health issues like heart disease, diabetes and cancer. Despite these risks, most men with low testosterone go untreated. "Low testosterone care has been stuck in the past, stigmatised, expensive and inaccessible for most men," said Andrew Dudum, founder and CEO of Hims & Hers. He added that the company aims to make treatment easily accessible and tailored to each patient's needs. To begin treatment, patients take an at-home blood test. Once results are available — typically within a few days — patients work with their provider to choose the best treatment plan, which may include ongoing at-home lab testing and provider check-ins, round-the-clock access to a care team, medication adjustments and educational resources available through the Hims app. Enclomiphene helps the body resume natural testosterone production without affecting fertility, according to Hims. The company also states that Kyzatrex restores testosterone levels in up to 96% of men, doubling free testosterone while maintaining a low side effect profile. "Marius developed Kyzatrex to modernise testosterone replacement therapy with an oral treatment backed by rigorous science and FDA approval," said Shalin Shah, CEO of Marius Pharmaceuticals. "Partnering with Hims & Hers allows us to bring this innovation to scale," he continued, adding that Hims' platform will help the drug reach millions of consumers. In addition to oral therapies, Hims plans to introduce injectable testosterone treatments through its digital platform in 2026.The expansion could serve as a new revenue-generating product line for the company as it distances itself from the regulatory uncertainties surrounding compounded weight-loss drugs. Hims took a huge financial hit after the FDA removed semaglutide from its shortage list, causing a sharp decline in sales of its compounded weight-loss offerings. It has also faced scrutiny from the FTC over its subscription practices and is battling investor lawsuits claiming the company misrepresented its financial status following its break-up with Novo Nordisk.

Acquisition

30 Jul 2025

·www.einpresswire.com

MOPE Clinic Highlights Clomiphene/Enclomiphene as Innovative Alternatives to Testosterone Replacement Therapy for Men

The Pros and Cons of Boosting Natural Testosterone Production with Selective Estrogen Receptor Modulators (SERMs) Clomiphene and Enclomiphene represent a revolutionary shift in how we manage low testosterone in men through enhancing the body’s natural hormone production as an alternative to traditional TRT.” — Chris Rue, FNP-C METAIRIE, LA, UNITED STATES, July 30, 2025 / EINPresswire.com / -- Metairie, LA– As the conversation around men’s hormonal health continues to grow, MOPE Clinic and Chris Rue, FNP-C are helping to lead the way in providing evidence-based options for testosterone optimization. One of the most compelling developments in this area is the use of medications like Clomiphene citrate and Enclomiphene citrate to stimulate the body’s own production of testosterone. These compounds, known as Selective Estrogen Receptor Modulators (SERMs), have gained popularity among men looking for an alternative to traditional testosterone replacement therapy (TRT). At MOPE Clinic, patients receive personalized, safe, and medically supervised hormone care tailored to their unique needs. What Are Clomiphene and Enclomiphene? Clomiphene citrate is a well-known fertility medication that has long been used in women. However, in recent years, it has found an important place in men’s health care. Enclomiphene, its purified isomer, has emerged as a more targeted treatment option with fewer estrogenic side effects. Both medications work by blocking estrogen receptors in the hypothalamus. This action tricks the brain into thinking estrogen levels are low, which leads to an increase in gonadotropin-releasing hormone (GnRH). In turn, GnRH stimulates the pituitary gland to produce luteinizing hormone (LH) and follicle-stimulating hormone (FSH). These hormones tell the testes to produce more testosterone and sperm. In other words, Clomiphene and Enclomiphene help reactivate the body’s natural testosterone production—a critical distinction from TRT, which replaces testosterone from external sources and often shuts down the body’s own production. The Benefits of Clomiphene and Enclomiphene At MOPE Clinic, Chris Rue, FNP-C emphasizes a holistic, functional approach to hormone optimization. In that light, Clomiphene and Enclomiphene offer several unique advantages: 1. Preservation of Fertility Unlike TRT, which can suppress sperm production, Clomiphene and Enclomiphene support spermatogenesis. This makes them ideal for younger men or those planning to maintain fertility while improving their testosterone levels. 2. Endogenous Testosterone Production These SERMs stimulate the body’s own production of testosterone. This avoids the testicular shrinkage and hypothalamic-pituitary-testicular axis (HPTA) suppression commonly seen with TRT. 3. Oral Administration Clomiphene and Enclomiphene are taken orally, typically as a pill taken daily or several times per week. This is more convenient than injections, gels, or pellets required in most TRT protocols. 4. Lower Risk of Erythrocytosis TRT can increase red blood cell count, raising the risk of blood clots. Clomiphene and Enclomiphene pose a lower risk for this complication. 5. Fewer Legal and Regulatory Concerns Clomiphene and Enclomiphene are not classified as controlled substances in the United States. This makes prescribing and accessing them more straightforward for both providers and patients. Who Is a Good Candidate? According to Chris Rue, FNP-C, ideal candidates for Clomiphene or Enclomiphene therapy include: Men under age 50 experiencing symptoms of low testosterone (fatigue, low libido, mood changes, etc.) Patients who still want to preserve fertility Individuals hesitant to start long-term TRT Men with secondary hypogonadism, where the problem lies in the brain or pituitary, not the testes At MOPE Clinic, patients undergo comprehensive lab testing, physical exams, and hormone assessments to determine whether Clomiphene or Enclomiphene is an appropriate treatment option. What Are the Limitations? Despite their many benefits, Clomiphene and Enclomiphene are not perfect solutions for every patient. At MOPE Clinic, education and transparency are key. Here are the primary limitations patients should consider: 1. Not Effective for Primary Hypogonadism If the testes are damaged or unresponsive (primary hypogonadism), Clomiphene and Enclomiphene won’t help. These medications require a functioning hypothalamic-pituitary-testicular axis. 2. Estrogenic Side Effects (Clomiphene) Some men experience visual disturbances, mood swings, or gynecomastia (breast tissue development) due to the mixed estrogenic effects of Clomiphene. Enclomiphene, being the purified isomer, generally causes fewer of these issues. 3. Variable Response Not all men respond the same. Some may see only modest increases in testosterone or symptom improvement. Ongoing monitoring is essential. 4. Off-Label Use Currently, neither Clomiphene nor Enclomiphene is FDA-approved specifically for male hypogonadism. However, off-label use is common and backed by numerous clinical studies. 5. Requires Patience and Follow-Up Clomiphene and Enclomiphene require several weeks to months to fully evaluate effectiveness. Frequent follow-up lab testing is necessary to track LH, FSH, estradiol, and testosterone levels. Research and Clinical Evidence Clinical studies have demonstrated the efficacy of Clomiphene citrate in raising testosterone levels in men with secondary hypogonadism. One study published in Fertility and Sterility showed that Clomiphene increased serum testosterone from an average of 247 ng/dL to 610 ng/dL after 3 months of therapy ( https://pubmed.ncbi.nlm.nih.gov/16422830/ } Another study in The Journal of Urology found that Enclomiphene significantly increased testosterone levels while maintaining sperm production—something not typically seen with TRT ( https://pubmed.ncbi.nlm.nih.gov/26496621/ ) MOPE Clinic’s Personalized Approach At MOPE Clinic, Chris Rue, FNP-C ensures that every patient receives a tailored treatment plan that considers hormonal balance, lifestyle, nutrition, and long-term health. Rather than treating labs alone, the clinic focuses on relieving symptoms, restoring well-being, and preserving function. Patients receive ongoing support, education, and adjustments to therapy as needed. Whether you’re struggling with fatigue, weight gain, low libido, or brain fog, MOPE Clinic offers a comprehensive, patient-first approach to hormonal health. Conclusion: A Modern Option for a Modern Man Clomiphene and Enclomiphene represent a revolutionary shift in how we manage low testosterone in men. By enhancing the body’s natural hormone production, these medications provide a compelling alternative to conventional testosterone replacement therapy. Still, they are not without limitations. At MOPE Clinic, men can expect evidence-based guidance, thorough evaluations, and compassionate care that respects their goals—whether that’s reclaiming energy, improving libido, or preserving fertility. Schedule a Consultation Today Men interested in learning whether Clomiphene or Enclomiphene is right for them can schedule a consultation at MOPE Clinic with Chris Rue, FNP-C. About MOPE Clinic MOPE Clinic is a leading hormone optimization and wellness center dedicated to improving men’s and women’s health through personalized, research-backed care. Led by Chris Rue, FNP-C, the clinic specializes in testosterone optimization, peptide therapy, weight loss solutions, and integrative functional medicine. Chris Rue Metairie Optimal Performance Enhancement +1 504-265-5491 email us here Visit us on social media: LinkedIn Instagram Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical Result

100 Deals associated with Enclomiphene citrate

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D10876	-	-	DB06735

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypogonadism	NDA/BLA	European Union	Renable Pharma Ltd.	25 Jan 2018
Bone Diseases, Metabolic	Phase 3	United States	Repros Therapeutics, Inc.	01 Sep 2012
Idiopathic Hypogonadotropic Hypogonadism	Phase 3	United States	Repros Therapeutics, Inc.	01 Aug 2012
Overweight	Phase 3	United States	Repros Therapeutics, Inc.	01 Aug 2012
secondary testicular failure	Phase 3	United States	Repros Therapeutics, Inc.	01 Mar 2006
Infertility	Phase 3	United States	FERRING BV	01 Feb 2005
Obesity	Phase 2	United States	Repros Therapeutics, Inc.	11 Jan 2016
Low testosterone levels	Phase 2	United States	Repros Therapeutics, Inc.	01 Jul 2011
Diabetes Mellitus, Type 2	Phase 2	United States	Repros Therapeutics, Inc.	01 Oct 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02651688 (CTgov)	Phase 2	Idiopathic Hypogonadotropic Hypogonadism \| Obesity	50	Enclomiphene (Enclomiphene 12.5 mg)	niyikykzuz(ossbcceyyh) = lvrpamuuhe zpgcclqybp (ciztjfmmnc, 7.08) View more	-	14 Jun 2019
				Enclomiphene (Enclomiphene 25 mg)	niyikykzuz(ossbcceyyh) = odzebcpbia zpgcclqybp (ciztjfmmnc, 7.88) View more
NCT01984398 (CTgov)	Phase 1	-	16	Androxal (12.5 mg Androxal Formulation A)	qarotktjlw(sqbrtgkntc) = clrdwsapkv plcuvgacgf (cwrfgghvkv, 0.349) View more	-	06 May 2019
				Androxal (25 mg Androxal Formulation A)	qarotktjlw(sqbrtgkntc) = soeuhzhwcr plcuvgacgf (cwrfgghvkv, 0.74) View more
NCT01386606 (CTgov)	Phase 2	secondary testicular failure	60	enclomiphene citrate (Androxal 6.25 mg)	itxzucfwgm(vzurrpvlut) = tlhdqkfjdc mruescoehl (cdzqwsmvon, 80.3) View more	-	23 Sep 2015
				enclomiphene citrate (Androxal 12.5 mg)	itxzucfwgm(vzurrpvlut) = fzcaatbyxt mruescoehl (cdzqwsmvon, 172.1) View more
NCT01532414 (CTgov)	Phase 3	secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism \| Overweight	151	Placebo (Placebo)	uopdxgsgzl = duspamgbbn zfwiswinxk (lendqdvyrw, apegisebbl - cmphadutlt) View more	-	27 May 2015
				Androxal (Androxal 12.5 mg)	rnxcdxeqnw(cpqgxojozl) = pdghykijzo itamnjwrxl (iclvnjdqzy, knxfoadjqt - hrjpyefctz) View more
NCT01739595 (CTgov)	Phase 3	secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism \| Overweight	181	Placebo (Placebo)	jnwfzaatwu = jltkaadqjf rrrioslcch (bodvicvrzl, odqqnnrtab - iamxpxuayr) View more	-	27 May 2015
				enclomiphene citrate (Androxal 12.5 mg)	djxniynxxf(hujhipdhjd) = ufyqanrlic xdjvsldwmb (clabgjqlgv, mglsfyrtfn - dstbrfahoz) View more
NCT01959685 (CTgov)	Phase 1	-	9	Androxal	clmlkgeudj(idkcqaoaen) = dhwhyekgcd lonznwkvta (anfjuhpqpo, 3.1) View more	-	11 Aug 2014
NCT01270841 (CTgov)	Phase 2	secondary testicular failure	83	Placebo (Placebo)	tdwyzmavgy(uarowpzivb) = whsearvyrh ysxdbhbiyy (lihmlpogcv, 47.5) View more	-	28 Jul 2014
				topical testosterone (Testim (Topical Testosterone))	tdwyzmavgy(uarowpzivb) = dozbttutpa ysxdbhbiyy (lihmlpogcv, 292.3) View more
NCT01534208 (CTgov)	Phase 3	secondary testicular failure	499	Androxal (Androxal 12.5 mg)	totubczplp(ijpggusnzw) = zhqyenkowv nbebhjhxdp (bvvxckxhzl, 141.4) View more	-	24 Jul 2014
				Androxal (Androxal 25 mg)	totubczplp(ijpggusnzw) = sfgozgwghp nbebhjhxdp (bvvxckxhzl, 154.7) View more
NCT01191320 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism	102	Placebo (Placebo)	bbtlydrsrc(foqzpspcpw) = hgpusqudim ufobohizne (xnpprphllv, 0.012) View more	-	24 Jul 2014
				Androxal (Androxal 12.5 mg)	bbtlydrsrc(foqzpspcpw) = kmhyrznmbs ufobohizne (xnpprphllv, 0.015) View more

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