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

175

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 ; Pasqualotto, Eric ; Ferreira, Rafael Oliva Morgado ; 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 Dec 2024·SCIENCE OF THE TOTAL ENVIRONMENT

Chemical profiling of organic contaminants in rural surface waters combining target and non-target LC-HRMS/MS analysis

Article

Author: Moreno-González, David ; Martínez-Piernas, Ana B. ; García-Reyes, Juan F. ; Fernández-García, Alfonso ; Martínez-Piernas, Ana B ; Gilbert-López, Bienvenida ; García-Reyes, Juan F

The pollution of natural waters by contaminants of emerging concern (CECs) is one of the pressing problems due to their global distribution and potential negative effects on the environment and human health. In rural areas with lower population density and limited industrial development, less contamination is expected. However, the lack of wastewater treatment plants (WWTPs) or their poor removal efficiency can lead to significant input of pollutants. In this context, 11 streams of rural areas in the Guadalquivir River basin, southeast of Spain, were studied over two years to obtain an overview of the origin and distribution of contaminants. A target method using solid-phase extraction and liquid chromatography coupled to high resolution mass spectrometry (LC-HRMS) was developed for the analysis of 316 compounds in surface waters. A total of 78 target analytes were detected, comprising pesticides, pharmaceuticals, personal care products (PCPs), transformation products (TPs), and industrial chemicals. The flame retardant tributyl phosphate (16-3572 ng L^-1) was detected in all samples, followed by caffeine (30-8090 ng L^-1) and the analgesic tramadol (3-1493 ng L^-1). The target approach was combined with a non-target analysis (NTA) strategy to obtain an overall perspective of the chemical profile of unexpected or unknown compounds in the samples. Up to 79 contaminants were tentatively identified, and 12 of them were finally confirmed with standards. Most of the contaminants determined by NTA were pharmaceuticals and their TPs. The results indicated that most of CECs have an urban origin despite traditional agriculture is the main economic activity in this region. Moreover, the absence of WWTPs in small towns is significant, as contamination levels at these sites were comparable to or higher than those in larger populations with sewage treatments.

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.

News (Medical) associated with Enclomiphene citrate

19 Dec 2025

·www.prnewswire.com

Feel30 Launches Austin-Based Telehealth Platform for Evidence-Proven TRT & Integrated At-Home Phlebotomy Services

AUSTIN, Texas, Dec. 19, 2025 /PRNewswire/ -- Feel30 , a telehealth platform specializing in testosterone replacement therapy and men's hormone optimization, has introduced a care model designed to improve access to clinically supervised treatment. Based in Austin, the service provides evidence-based TRT, enclomiphene treatment, and erectile dysfunction medications prescribed by licensed U.S. clinicians, with medications fulfilled through licensed U.S. pharmacies. Continue Reading Feel30 was founded on 22nd February 2025, by entrepreneur Thomas Phillips, who sought to address common problems in traditional hormone care, including long wait times, multiple in-person lab visits, slow or delayed pharmacy compounding, confusing pricing with hidden fees, and rigid schedules. Feel30 launches national telehealth TRT with at-home nurse blood draws. Post this Internal data from Feel30's early patient population shows that 40% of men seek evaluation primarily due to sustained low energy compared to earlier stages of life, while 30% enroll after relocating to a new state and needing continuity of TRT care. Service features include transparent all-inclusive pricing, quarterly at-home nurse blood draws, home or in-clinic lab flexibility, unlimited clinician consultations, discreet pharmacy fulfillment, and scheduling on patients' terms. The initial laboratory panel costs $99 to $129 and includes the lab test, the at-home nurse visit or in-clinic option, the medical intake, and the clinician review. Ongoing treatment starts at $199 to $235 per month and includes medication, quarterly at-home nurse blood draws, unlimited clinician consultations, follow-up care, medication management, and discreet shipping. There are no upsells or hidden fees. The care process begins with a comprehensive blood panel to evaluate testosterone levels and related biomarkers. Patients can receive at-home nurse visits as early as the next day, with optional in-clinic laboratory testing available. Feel30's licensed clinicians review results and issue prescriptions only when medically appropriate and aligned with established guidelines. Most patients complete their initial evaluation within 48 to 72 hours. Feel30 is one of the only national TRT providers offering quarterly at-home phlebotomy included in the base membership price, positioning it as a leading option for men seeking convenient, medically supervised hormone therapy. According to established Endocrine Society guidelines, testosterone therapy should only be prescribed after laboratory testing confirms low testosterone. Testosterone levels naturally decline with age, and clinically low levels may be associated with symptoms like fatigue, reduced libido, decreased muscle mass, increased body fat, and lower motivation. Enclomiphene may be used to increase endogenous testosterone production while preserving fertility. "Many men experience delays in hormone evaluation because of limited appointment availability or the inconvenience of accessing laboratory services," said Anneliese Cadena, AGNP-C, board-certified Nurse Practitioner and consultant for Feel30. "Telehealth combined with at-home diagnostics allows timely evaluation and guideline-based prescribing with ongoing medical oversight." Telehealth continues to increase in men's hormone care as patients seek faster evaluation and more flexible access to licensed clinicians. Integrated care models allow clinicians to assess laboratory data remotely, prescribe treatment, and follow up with patients. Media Contact: Thomas Phillips, [email protected], 833-545-1589 **About Feel30** Feel30 is based in Austin, Texas. The platform provides evidence-based testosterone therapy, enclomiphene treatment, and men's health services with all-inclusive pricing, at-home lab testing with nurse visits, unlimited clinician support, and fast U.S. pharmacy fulfillment. The company's mission is to make evidence-based hormone care clearer, faster, and more accessible for busy men nationwide who refuse to wait. SOURCE Feel30 21% more press release views with Request a Demo

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

100 Deals associated with Enclomiphene citrate

External Link

KEGG	Wiki	ATC	Drug Bank
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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02651688 (CTgov)	Phase 2	Idiopathic Hypogonadotropic Hypogonadism \| Obesity	50	Enclomiphene (Enclomiphene 12.5 mg)	lsnyakucpt(flugobulyt) = cvpfelzzcd cheerysjvc (izwihxirmz, 7.08) View more	-	14 Jun 2019
				Enclomiphene (Enclomiphene 25 mg)	lsnyakucpt(flugobulyt) = lnygwqekuw cheerysjvc (izwihxirmz, 7.88) View more
NCT01984398 (CTgov)	Phase 1	-	16	Androxal (12.5 mg Androxal Formulation A)	dhgbudrbbu(xoutuqrcnn) = yawmowzvod lxrkdfjjvc (xgqunqcyce, 0.349) View more	-	06 May 2019
				Androxal (25 mg Androxal Formulation A)	dhgbudrbbu(xoutuqrcnn) = uvrbygttae lxrkdfjjvc (xgqunqcyce, 0.74) View more
NCT01386606 (CTgov)	Phase 2	secondary testicular failure	60	enclomiphene citrate (Androxal 6.25 mg)	gcnfpwtgka(fyzuhigsee) = cogfcwfdno yktlrcbrse (hlkxczrvzi, 80.3) View more	-	23 Sep 2015
				enclomiphene citrate (Androxal 12.5 mg)	gcnfpwtgka(fyzuhigsee) = vmvzkeywvz yktlrcbrse (hlkxczrvzi, 172.1) View more
NCT01532414 (CTgov)	Phase 3	secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism \| Overweight	151	Placebo (Placebo)	opuhmvjgaz = jeusayihtb qxmnwvoxxe (zqagrycmgo, sicozsufzl - yhajjjhcbw) View more	-	27 May 2015
				Androxal (Androxal 12.5 mg)	ppisiifltx(tayfwclafi) = khdisrkjsx ajlfxohmaz (kwtwnkmvax, jfxbwohnyq - acpsadrigc) View more
NCT01739595 (CTgov)	Phase 3	secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism \| Overweight	181	Placebo (Placebo)	oqgywxwqfs = jvnqivansa dhaexjeyco (bhhbtcjsoz, ljksrkrvkz - ecdtpasslp) View more	-	27 May 2015
				enclomiphene citrate (Androxal 12.5 mg)	dsgwzragqh(jueccbvefp) = ktzmqftkny ympecwykhh (bhanbdbmdn, fjlifpztak - vimltznswm) View more
NCT01959685 (CTgov)	Phase 1	-	9	Androxal	krfzrztgqu(wekciorgvr) = dkzceudgho enpkldeces (jfqenuydpk, 3.1) View more	-	11 Aug 2014
NCT01270841 (CTgov)	Phase 2	secondary testicular failure	83	Placebo (Placebo)	xfrqcvqxhx(czlisrksjh) = sookbdrymh piocycttbw (taerswbwip, 47.5) View more	-	28 Jul 2014
				topical testosterone (Testim (Topical Testosterone))	xfrqcvqxhx(czlisrksjh) = gqyqymctki piocycttbw (taerswbwip, 292.3) View more
NCT01534208 (CTgov)	Phase 3	secondary testicular failure	499	Androxal (Androxal 12.5 mg)	spavudkpct(ztunanecss) = igjzyvvtnk rzblxcmbea (unvohiisdu, 141.4) View more	-	24 Jul 2014
				Androxal (Androxal 25 mg)	spavudkpct(ztunanecss) = paxkmxanlp rzblxcmbea (unvohiisdu, 154.7) View more
NCT01191320 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| secondary testicular failure \| Idiopathic Hypogonadotropic Hypogonadism	102	Placebo (Placebo)	hmulpbdlly(ssycftyiun) = sxehpzxxkv zuywmuwfkt (ktsyuxhbpj, 0.012) View more	-	24 Jul 2014
				Androxal (Androxal 12.5 mg)	hmulpbdlly(ssycftyiun) = lxoapjtwpp zuywmuwfkt (ktsyuxhbpj, 0.015) View more

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