Interest of Clomiphene Citrate (CC) Associated With a Second Testicular Sperm Extraction (TESE) in Patients With Non-obstructive Azoospermia (NOA) After Failure of a First TESE, on the Quantity of Sperm Cells Available for Intracytoplasmic Sperm Injection (ICSI). Randomized Double Blind Trial Versus Placebo.

In the absence of sperm in the semen (azoospermia), there is no chance of natural paternity. It is found in about 1% of men and is either due to an obstruction of the seminal tracks (obstructive azoospermia (OA)) in 1/3 of the cases, or a spermatogenic failure (non-obstructive azoospermia (NOA)) in 2/3 of the cases. To date, no medical treatment had proved its efficiency to induce spermatogenesis in case of NOA.
The development of Intracytoplasmic sperm injection (ICSI) in 1992 allowed to obtain pregnancies from a small number of spermatozoa. The next year, testicular sperms were extracted from testicular tissue obtained surgically in cases of OA , allowing paternity for azoospermic men. In case of NOA, TESE allowed to obtain few sperms in an unexpected number of cases. It was shown that spermatogenesis remains active in rare portions of seminiferous tubules, a phenomenon called focal spermatogenesis, which allows to extract testicular sperms with an average SRR of 50%, and to obtain pregnancy by ICSI. Thus, TESE-ICSI revolutionized the prognosis of NOA, however, half of the cases of NOA had no sperm extracted and remained sterile . Since sperm donation and adoption are unacceptable for several of these couples, there is a real demand for additional treatment.
Two ways to improve chances of paternity in case of NOA are currently discussed:
1. Proceed to a second attempt of TESE. Since the first attempt could have missed a focus of active spermatogenesis, the chance for a positive second TESE is not null even. Reviewing the few articles published on this issue , the SRR for the second attempt, after a first negative attempt averaged 25%.
2. Based upon the decrease of testosterone production within the testis in case of NOA and the potential increased of the focal spermatogenesis by gonadotropins, few reports of hormonal therapy in case of NOA have been published and suggested a positive effect of hormonal therapy.
This prompted us to develop this clinical trial to investigate the effect of Clomiphene Citrate versus placebo on the results of a second TESE in NOA.
Results of hormonal therapy in case of NOA were heterogeneous and of poor methodological quality, none was randomized versus placebo: Anti-aromatases or Gonadotropins administered before the first TESE or the second TESE gave positive results. Hussein at al in 2013, suggested a positive effect of Clomiphene citrate (CC), administrated before the first TESE (57% of the CC treated group versus 33.6% in not treated group) but with drop out of patient positive to sperm analysis. However, in these positive studies, sample sizes were small or selected patients on hormonal status or histology criteria suggesting subgroup of favourable NOA. Thus, there is no strong evaluation of the interest of hormonal treatment in NOA, after a negative first TESE.
The investigators decided to evaluate the effect of the CC, the most convincing and convenient hormonal treatment, in patients with negative first TESE for NOA. It is of main interest to known if CC could enhance the SRR of a second TESE, that is the ultimate possibility to have their own child for these patients.

Start Date01 Jan 2026

Sponsor / Collaborator

Hospices Civils de Lyon

NCT06701071

/ RecruitingPhase 4IIT

Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients With Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of mature eggs retrieved.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Southern California

CTRI/2025/04/084166

/ Not yet recruitingNot Applicable

To assess the efficacy of clomiphene citrate flare effect in the flexible antagonist protocol versus ultra short flare agonist protocol in diminished ovarian reserve. - NIL

Start Date10 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Clomiphene Citrate

100 Translational Medicine associated with Clomiphene Citrate

100 Patents (Medical) associated with Clomiphene Citrate

6,079

Literatures (Medical) associated with Clomiphene Citrate

01 Nov 2025·European Journal of Obstetrics & Gynecology and Reproductive Biology

Ovarian response in natural cycle, minimal stimulation and conventional IVF protocols in relation to anti-mullerian hormone level – A multi-center study

Article

Author: Bohlen, U ; von Arnim, L ; Nordin, M ; Popovici, R M ; von Wolff, M ; Lühr, B ; Lanowski, J-S ; Roumet, M ; Arni, A ; Eisenhardt, S ; Magaton, I ; Siercks, I ; Reeka, N

BACKGROUND:

In addition to conventional in-vitro-fertilization IVF (cIVF) alternative protocols such as natural cycle (NC-) and minimal stimulation (Min stim-) protocols allow individualized IVF and oocyte freezing treatments. The objective was to develop a model to predict ovarian response in relation to different stimulation protocols and anti-mullerian hormone (AMH) levels.

METHODS:

International multi-centre retrospective cohort study including 1504 NC-IVF, 1287 Min stim IVF and 2048 cIVF cycles performed 01.2022-03.2023. Min stim protocols consisted of oral compounds such as low dose clomiphene citrate or aromatase inhibitors alone or in combination with low dose gonadotropins. Negative binomial regression models were used to assess the effect of protocol and AMH level on the number of oocytes and secondarily on zygotes. Predictions of outcomes were derived across protocols and different AMH categories (<1, ≥1-<2, ≥2 ng/ml).

RESULTS:

AMH is an effective predictor of the number of oocytes in relation to IVF protocol. Number of oocytes increase in protocols including gonadotropins, but not in protocols with only oral compounds. Effect of stimulation increased with increasing AMH level but was less pronounced with low AMH level. For example, if AMH is < 1 ng/ml, the predicted number of oocytes is 0.85 and 4.04 in the NC- and cIVF protocols, whereas the difference is twice as large with AMH ≥ 2 ng/ml with predicted values of 0.83 and 10.54, respectively.

CONCLUSION:

Based on AMH level, Min stim-protocols can be individualized by selecting specific stimulation protocols according to the predicted ovarian response, especially in cases with low ovarian reserve.

03 Oct 2025·AMERICAN JOURNAL OF VETERINARY RESEARCH

Intravenous clomiphene citrate pharmacokinetics in healthy mares as a first step toward use in reproduction

Article

Author: Thungrat, Kamoltip ; Cruz-Espindola, Crisanta ; Moore, Hayley L. ; Klabnik, Jessica L. ; Boothe, Dawn M. ; Babu, R. Jayachandra ; Mita, Nur ; Lyman, Candace C.

Abstract:

Objective:

To investigate the IV pharmacokinetic parameters of clomiphene citrate (CC), a selective estrogen receptor modulator, in mares.

Methods:

This was an experimental study to assess the pharmacokinetic parameters of CC in the mare. Eight mares received a single 2,000-mg dose of IV CC to identify plasma concentrations over 336 hours. Following this, 6 mares received a multidose regimen of IV CC (2,000 mg, q 24 h) for 5 days to identify trough plasma concentration each day.

Results:

CC was well tolerated, demonstrated a short elimination half-life of 4.95 ± 1.10 hours and a mean residence time of 7.14 ± 1.59 hours, and reached plasma drug concentrations considered to be therapeutic in women. Peak and trough plasma concentrations were determined.

Conclusions:

IV CC at 2,000 mg reaches presumed therapeutic concentrations in the mare. Based on the multidose trial, 2,000 mg of IV CC may require administration every 12 to 24 hours.

Clinical Relevance:

IV CC appears to be well tolerated in the mare. Future fertility trials are warranted to assess the potential that CC may have in increasing the efficiency of equine in vitro embryo production.

01 Oct 2025·JOURNAL OF MOLECULAR HISTOLOGY

Kaempferol alleviates cypermethrin induced reproductive toxicity in rats via Nrf2-mediated antioxidant and apoptotic regulation with histopathological evidence: in vivo and in silico study

Article

Author: Din, Hafiz Misbah Ud ; Usman, Muhammad ; Nazir, Sadaf ; Anjum, Shaista ; Azeem, Muhammad ; Khan, Nazima Yousaf ; Buzdar, Jameel Ahmed ; Behan, Atique Ahmed ; Arshad, Muhammad Adeel ; Cheng, Shiping ; Kabeer, Fahad

Cypermethrin (CYP), a common synthetic pyrethroid pesticide, is associated with oxidative stress-mediated female reproductive toxicity. With increasing concern over reproductive failures, exploring natural alternatives to mitigate this problem is crucial. For this purpose, thirty-six female SD rats were divided into six different (n = 6) groups such as negative control (group I), while disease control (group II) was treated to CYP-induced toxicity. Group III received 5 mg/kg Clomiphene Citrate, a standard drug, and groups IV, V, and VI were subjected with Kaempferol (KAE) dosage of 25, 50 and 100 mg/kg, respectively, for 14 days after induction of toxicity. CYP exposure significantly impaired the fertility status of female rats, disrupted the estrous cycle, altered ovarian and uterine coefficients. It also reduced antioxidant enzyme activity while elevating malondialdehyde levels. KAE supplementation effectively reversed these changes by restoring fertility status, normalizing antioxidant enzyme activity and reducing MDA levels, and improving ovarian and uterine coefficients. Histopathological analysis revealed preserved uterine and ovarian integrity in KAE-treated groups. Furthermore, KAE regulated the mRNA expression of key apoptotic and oxidative stress markers including Bcl2, Bax, caspase-3, caspase-9, and Nrf2. Further, gene ontological study revealed that these genes are involved in apoptotic signaling, immune homeostasis and neuronal regulation due to strong enrichment in mitochondrial and protease related function. Molecular docking analysis demonstrated that KAE exhibited significantly, inhibit Nrf2-KEAP1 bonding compared to Clomiphene citrate, indicated by well docking score. It is concluded that KAE holds therapeutic potential as a safe, natural alternative to combat CYP induced oxidative stress, apoptosis, and reproductive toxicity.

News (Medical) associated with Clomiphene Citrate

30 Jul 2025

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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

17 Jun 2025

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Perform Medical Launches Comprehensive Hormone Balancing Program for Men and Women in the Greater Charleston Area

SUMMERVILLE, SC, UNITED STATES, June 17, 2025 / EINPresswire.com / -- Perform Medical , a premier wellness clinic serving the Lowcountry, proudly announces the launch of its advanced, personalized hormone balancing programs for both men and women. Under the clinical leadership of Taylor Vaughan, Medical Director, MBA, and Kaley Morris, Physician Assistant, the initiative offers an integrative, results-driven approach to correcting hormonal imbalances that impact health, vitality, and quality of life. At Perform Medical, the mission is clear: Reclaim Your Health, Hormone by Hormone. With the understanding that hormone shifts are a natural part of aging, the clinic empowers patients to stop merely enduring the symptoms and instead regain their energy, clarity, and confidence through customized hormone therapy. Why Hormone Balance Matters Hormones govern nearly every system in the human body—from metabolism and mood to sexual health and mental clarity. When these powerful messengers fall out of sync, patients may experience symptoms such as: - Chronic fatigue and poor sleep - Weight gain and muscle loss - Mood swings, anxiety, and depression - Low libido and sexual dysfunction - Brain fog and poor concentration - Hot flashes and night sweats Whether the imbalance stems from aging, menopause, andropause, or chronic stress, Perform Medical’s team addresses the root causes with medical precision and compassionate care. Tailored Care for Men Men facing symptoms of low testosterone—such as reduced motivation, decreased muscle mass, erectile dysfunction, and mental fog—can benefit from Perform Medical’s Testosterone Replacement Therapy (TRT). The clinic offers multiple delivery options, including bio-identical hormone pellets, injections, and fertility-preserving alternatives like Clomiphene or Enclomiphene. Each program begins with advanced hormone panel testing and includes ongoing lab monitoring to ensure optimal, long-lasting results. Estrogen blockers are also available to help manage potential side effects, ensuring that each plan is customized to the individual’s goals and lifestyle. Empowering Women Through Every Life Stage For women navigating perimenopause, menopause, or postmenopause, Perform Medical delivers cutting-edge bio-identical hormone replacement therapy (BHRT) to alleviate hot flashes, mood instability, low libido, and more. Led by Kaley Morris, PA-C, the women’s program includes pellet therapy, topical hormone creams, and integrated wellness support to restore balance naturally and effectively. The clinic’s BHRT pellets—plant-based and structurally identical to human hormones—offer long-term, steady-release dosing without the daily hassle of pills or creams. They are a preferred option for women seeking consistent relief and convenience. The Perform Medical Difference Perform Medical stands out for its deep specialization in hormonal health, evidenced by: - Expert Clinicians: Board-certified providers with advanced training in hormone therapy - Individualized Care Plans: No cookie-cutter protocols—just precision medicine based on lab data and symptoms - Local Support: A patient-first approach rooted in the Charleston community - Whole-Body Wellness: Hormone therapy integrated with sexual wellness, medical weight loss, and functional health programs Now Serving the Greater Charleston Area Perform Medical is currently welcoming patients from Summerville, Charleston, Mount Pleasant, Daniel Island, Isle of Palms, Sullivans Island, Kiawah Island, Moncks Corner, Goose Creek, and North Charleston. Is Hormone Therapy Right for You? If you’ve asked yourself questions like: - “Why am I tired all the time?” - “Is there a better way to handle menopause?” - “What can I do about brain fog and low libido?” - “Where can I get testosterone therapy in Charleston?” …it may be time to explore your hormonal health. To learn more or schedule their personalized hormone consultation, individuals can contact Perform Medical today at (843) 278-8474. About Perform Medical Perform Medical is a functional wellness clinic based in Charleston, SC, specializing in hormone health, sexual wellness, regenerative medicine, and medical weight loss. Led by Dr. Taylor Vaughan and Kaley Morris, PA-C, the clinic is dedicated to restoring health through advanced diagnostics, evidence-based therapies, and compassionate care. Taylor Vaughan, MD, MBA Perform Medical +1 843-278-8474 email us here Visit us on social media: 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.

Executive Change

16 Oct 2024

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KYZATREX® (testosterone undecanoate) CIII Capsules Featured in Research at the Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting

RALEIGH, N.C., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce that KYZATREX® (testosterone undecanoate) CIII capsules will be highlighted in three research abstracts at the upcoming Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting taking place from October 17th to 20th in Scottsdale, Arizona. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The abstracts being presented include: "Combined Clomiphene and High-Dose Oral Testosterone Therapy in Hypogonadal Men: A Case Series" – This study, conducted by Dr. Andrew Sun, Grace Yoon BS, and Jimmy Vo BS, explores the effects of combining clomiphene with high-dose oral testosterone therapy, highlighting a novel approach to optimizing treatment outcomes for hypogonadal men. Dr. Sun will present this abstract."Initiating High-Dose Oral Testosterone Undecanoate Therapy in Hypogonadal Men" – This research, conducted by Dr. Andrew Sun, Jimmy Vo BS, and Grace Yoon BS, focuses on the initiation process for high-dose oral testosterone undecanoate therapy, offering valuable data for clinicians considering this treatment option for men with testosterone deficiency. Dr. Sun will present this abstract."Effects of Oral Testosterone Undecanoate on Semen Parameters in Hypogonadal Men: An Interim Analysis of a Prospective Pilot Study" – Presented by Gal Saffati, this study examines the impact of oral testosterone undecanoate on semen parameters, providing new insights into its effects on fertility in hypogonadal men. “We are proud to see KYZATREX featured in these important studies at the SMSNA Annual Meeting, contributing to a deeper understanding of testosterone therapy and its potential benefits for men with hypogonadism,” said Amit Shah, COO of Marius Pharmaceuticals. “These findings highlight the value of exploring new avenues in oral testosterone treatment.” The SMSNA Annual Fall Scientific Meeting gathers leading experts in sexual medicine, providing a platform for sharing innovative research and best practices. Marius Pharmaceuticals remains committed to advancing the science of testosterone therapy and improving outcomes for patients with testosterone deficiency. About KYZATREX® (testosterone undecanoate)KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius PharmaceuticalsMarius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com. Important Safety Information for KYZATREX® (testosterone undecanoate)UseKYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.Important Safety Information for KYZATREX® (testosterone undecanoate) KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.If your blood pressure cannot be controlled, KYZATREX may need to be stopped.Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.Increased risk of prostate cancer.Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.In large doses, KYZATREX may lower your sperm count.Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).Swelling of your ankles, feet, or body (edema), with or without heart failure.Enlarged or painful breasts.Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above.The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children.See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact: Lilly Washburnlilly@mariuspharma.com

Clinical ResultPhase 3

100 Deals associated with Clomiphene Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00962	Clomiphene Citrate	G03GB02	DBSALT000490

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Oligospermia	Japan	Fuji Pharma Co., Ltd.	11 Mar 2022
Infertility	United States	Sanofi-Aventis U.S. LLC	01 Feb 1967

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	China	Ferring Holding SA	17 Oct 2013
Infertility, Female	Phase 3	China	Ferring GmbH	17 Oct 2013
Infertility, Female	Phase 3	China	Ferring Arzneimittel Gmbh	17 Oct 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05206448 (CLC II, CTgov)	Phase 4	Polycystic Ovary Syndrome \| Infertility \| Anovulation	190	letrozole (Letrozole)	nkedntssqe = wrddeeljhe hfrgpmevdp (tibtwdtvxh, sywrwkuzqx - jpnbwhieev) View more	-	15 Apr 2025
				letrozole+Clomiphene citrate (Letrozole + Clomiphene Citrate)	nkedntssqe = cynkarbetd hfrgpmevdp (tibtwdtvxh, jzzgfmwwqh - pqthlperjr) View more
NCT00068861 (Pregnancy in Polycystic Ovary Syndrome I (PPCOS I), Pubmed \| Fertil Steril)	Phase 3	Polycystic Ovary Syndrome anti-Müllerian hormone (AMH)	333	Clomiphene	tgumtspsnx(xcivozeuvw) = ptlgdkoexn gngigdjvbt (zycttodhbv, 8.3)	-	01 Apr 2024
				Metformin	tgumtspsnx(xcivozeuvw) = nnktmczazu gngigdjvbt (zycttodhbv, 8.3)
NTR1449 (M-ovin trial, Pubmed \| Hum Reprod)	Not Applicable	-	666	Gonadotrophins	xwwerkyygc(oeldmwwjeh) = fdclkytooq afhkerptae (fgmotccgyd ) View more	-	01 Mar 2023
				Clomiphene citrate (CC)	xwwerkyygc(oeldmwwjeh) = egqqshptmo afhkerptae (fgmotccgyd ) View more
NCT01718444 (CTgov)	Not Applicable	Polycystic Ovary Syndrome \| Infertility	27	Clomiphene citrate (Group A (No PIES))	gfagsicsbm(mgvicuglhs) = dzsifmlvkl jqvyrsogfu (dttfrratwt, llxgmcmocx - puvvyrggkq) View more	-	29 Sep 2020
				Progestin+Clomiphene citrate (Group B (PIES Group))	gfagsicsbm(mgvicuglhs) = wvicvsikii jqvyrsogfu (dttfrratwt, pbpwznsdlv - wtbxcnibfa) View more
NTR1449 (MOVIN, Pubmed \| Hum Reprod)	Not Applicable	Anovulation First line	666	Gonadotrophins	okidspwgwt(dmkiuahmym) = aqznrlwgdb hwzskqkmum (gledorluyg, 1.13 - 2.19)	-	01 Jun 2020
				Clomiphene citrate	okidspwgwt(dmkiuahmym) = ifxcepsjkw hwzskqkmum (gledorluyg, 1.13 - 2.19)
NCT02710981 (CTgov)	Not Applicable	Infertility \| Anovulation	42	Clomiphene Citrate (Clomiphene Citrate Only Group (6th Ovulation Induction Cycle))	mlwgvflkyr(fvjybldwca) = ziymswsvng jybyszukll (qzalcwcnsu, 1.4) View more	-	05 May 2020
				Sildenafil+Clomiphene Citrate (Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation))	mlwgvflkyr(fvjybldwca) = nusvbaokvg jybyszukll (qzalcwcnsu, 3.1) View more
NCT03933618 (CAP, CTgov)	Phase 2	Eunuchism	24	Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-clomiphene-placebo)	uahwdgoztp = wxjahgoerk ywdmqymwzy (nhlydszolc, psdchadtkt - frgkcyjoxs) View more	-	18 Nov 2019
				Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-placebo-clomiphene)	uahwdgoztp = aejvaluupr ywdmqymwzy (nhlydszolc, awpygpjsus - nfmvskkirv) View more
NCT02802865 (CTgov)	Phase 4	Polycystic Ovary Syndrome \| Infertility	70	Letrozole (Letrozole)	iryvecwoio = ojfjtlkuzf lmewxkgtne (blolgajqng, rvkxrynpww - jqkknhcnzy) View more	-	27 Sep 2019
				Clomiphene+Letrozole (Letrozole + Clomiphene)	iryvecwoio = zbtsmsuuwx lmewxkgtne (blolgajqng, rfywbhszzw - cicqbvuntb) View more
NCT02274311 (CTgov)	Phase 2	Acromegaly	16	Clomiphene citrate	zfhpjfqjcq(zvlyufzmek) = qjeoxmpzei bgipoqzugt (bbatjosuvz, 108) View more	-	07 May 2019
NCT01921166 (Diminished Ovarian Reserve, CTgov)	Phase 4	Infertility	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	kvtenxieli = xfqfezhzuj nxfgzrbzey (stypgvxujv, naukokjrhi - kztofbjagp) View more	-	23 Feb 2018
				Leuprolide flare (Leuprolide Flare)	kvtenxieli = ncynznsogx nxfgzrbzey (stypgvxujv, rvapyslrfi - unxizhepqx) View more

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