Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain.
This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first two years of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 4 visits:
* before starting T
* after 6 months on T
* after 1 year on T
* after 2 years on T
At the visits, they will be asked to:
* answer questions and surveys about their health
* have a brain MRI done
* give a small sample of blood
and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.

Start Date01 Nov 2024

Sponsor / Collaborator

University of Colorado Denver

NCT06294990 / RecruitingNot ApplicableIIT

Klinefelter Syndrome - the Effect of Testosterone Treatment In Puberty. A Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'

The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).
The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.
Participants will be randomized to two years treatment with testosterone or placebo.

Start Date15 Aug 2024

Sponsor / Collaborator

Rigshospitalet

100 Clinical Results associated with Testosterone

100 Translational Medicine associated with Testosterone

100 Patents (Medical) associated with Testosterone

60,905

Literatures (Medical) associated with Testosterone

01 May 2025·Journal of Environmental Sciences

The effects of 17β-trenbolone and bisphenol A on sexual behavior and social dominance via the hypothalamic-pituitary-gonadal axis in male mice

Article

Author: Sun, Minghe ; Luan, Jialu ; Zhao, Qili ; Zhang, Shuhui ; Feng, Xizeng ; Bai, Huijuan ; Sun, Mingzhu ; Zhao, Xin ; Yu, Qian ; Fu, Zhenhua ; Zuo, Xiang

17β-Trenbolone (17-TB) is well documented as an environmental endocrine disruptor in aquatic biological studies, but its effects on mammals remain poorly understood. Furthermore, 17-TB acts as a hormone with properties similar to testosterone, and the consequences of juvenile exposure on adult social behavior remain uncertain. Bisphenol A (BPA) acts as an estrogen-like hormone, compared to 17-TB. Three-week-old male Balb/c mice were exposed orally to 17-TB (100 µg/(kg·day)) and BPA (4 mg/(kg·day)) for 28 days. Assessments of social interactions and a three-chamber test showed that 17-TB increased virility in male mice, intensified both male and female sexual behavior, and attracted and accepted female mice. It also increased social dominance through tube tests in male mice and markedly activated the c-Fos⁺ immune response in the medial prefrontal cortex (mPFC) and basal amygdala (BLA). ELISA data showed that 17-TB and BPA exposure significantly affected serum gonadotropin-releasing hormone (GnRH), growth hormone (GH), estradiol (E2), and luteinizing hormone (LH) levels, as well as testicular lesions and androgen receptor (ARβ) and estrogen receptor (ERα) synthesis. Testicular transcriptomic analysis further confirmed that could disrupt steroid synthesis and linoleic acid-related biometabolic processes. These findings suggest the influence of 17-TB and BPA exposure on sexual behavior and fertility in male mice, possibly through modulation of the hypothalamic-pituitary-gonadal axis. This study provides insights relevant to human reproductive health and neuro-social behavioral research, and the potential risk of environmental disturbances should not be overlooked.

01 Mar 2025·Journal of Orthopaedics

Geographical incidence of testosterone supplementation in total hip and knee arthroplasty

Article

Author: Kuznetsov, Mikhail ; Smith, Eric L ; Grant, Andrew ; Coden, Gloria ; Smith, Eric L.

Introduction:

Prescription testosterone usage in the United States declined after 2013 following reports of its association with myocardial infarction and stroke. However, more recently there has been a documented increase in testosterone prescriptions. Recently, testosterone levels have also been hypothesized to increase infection risk in patients undergoing elective shoulder arthroplasty. Furthermore, testosterone may increase the risk of venous thromboembolism. These complications are perioperative concerns for total hip and knee arthroplasties (THA/TKA). Therefore, the purpose of our study is to identify trends in the incidence of testosterone prescriptions in patients who underwent THA/TKA with respect to geographical population data.

Methods:

We retrospectively reviewed 40,711 primary THAs and 50,893 primary TKAs performed in males between 1/1/2016 and 12/31/2021 using a commercial claims database. Records were reviewed for demographics, geographical location, and supplemental testosterone prescriptions within 1 year prior to surgery. Patient Metropolitan Statistical Area (MSA) was assessed with respect to United States Census Population Data.

Results:

We identified 91,604 males who underwent primary THA (n = 40,711) or TKA (n = 50,893). For THA/TKA, patients who were younger had a higher likelihood of having a supplemental testosterone prescription (OR = 0.99, 95 % CI [0.99-1.00], p < 0.001). TKA patients (2,507, 4.9 %) had a higher rate of testosterone prescriptions than THA patients overall (1,413, 3.4 %), (OR = 1.44 95 % CI [1.35, 1.54], p < 0.001) as well as within each year.For THA and TKA patients, patients in the Midwest (OR = 1.61, p < 0.001), South (OR = 3.04, p < 0.001), and West (OR = 2.28, p < 0.001) regions all had higher testosterone prescription rates than the Northeast. Patients living in a city (MSA population ≥200,000) were more likely to be prescribed testosterone (OR = 1.20, p = 0.002).

Conclusion:

Surgeons conducting TKA/THA should be aware that younger patients, those in higher population areas, and those in the Midwest, South, and West regions are more likely to be prescribed testosterone than those in the Northeast.

01 Jan 2025·BEHAVIOURAL BRAIN RESEARCH

Effects of combined postweaning social isolation and ketamine administration on schizophrenia-like behaviour in male Sprague Dawley rats

Article

Author: Luvuno, Mluleki ; Shangase, Khanyiso Bright ; Mabandla, Musa

The pathophysiology behind negative and cognitive symptoms of schizophrenia is not well understood, thus limiting the effectiveness of treatment on these symptoms. Developing reliable animal model of schizophrenia is vital to advance our understanding on the neurobiological basis of the disorder. Double hit is used to refer to the use of two schizophrenia inducing interventions viz ketamine exposure and social isolation. In this study we aim to investigate the robustness of double hit model of schizophrenia in inducing negative and cognitive symptoms of schizophrenia. On postnatal day (PND) 23, thirty-two male Sprague Dawley rats were randomly grouped into four equal groups as follows: group housed + saline (GH), group housed + ketamine (GHK), isolated + saline (SI), and isolated + ketamine (SIK). A single ketamine dose (16 mg/kg) was administered 3 times a week for four weeks. Isolated animals were housed singly throughout the study. The following behavioural tests were carried out: elevated plus maze, three chamber social interaction, resident intruder tests, and novel object recognition (NOR). The SIK group exhibited high anxiety levels, with increased ACTH, corticosterone and norepinephrine concentration when compared to the other groups. The SIK animals also presented with reduced social interaction and decreased oxytocin concentration. SIK rats were more aggressive towards a juvenile intruder but had low testosterone concentration. The SIK group or double hit model showed impaired visual learning and memory and increased expression of proinflammatory cytokines. This suggest that the double hit model is more robust in inducing negative and cognitive symptoms of schizophrenia than each treatment alone.

195

News (Medical) associated with Testosterone

14 Nov 2024

·www.globenewswire.com

New Data from Marius Pharmaceuticals Reveals High Prevalence of Low Libido, Energy and Quality of Life in Men

RALEIGH, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has released compelling new insights from a recent Androgen Deficiency in Aging Males (qADAM) questionnaire conducted on their KYZATREX® (testosterone undecanoate) CIII capsules website. The data collected from 779 participants highlights significant challenges faced by men regarding energy, libido, strength and overall life satisfaction, underscoring the potential impact of testosterone deficiency on quality of life and well-being. Below are the results from men who responded to the qADAM questionnaire, a validated tool for assessing testosterone deficiency symptoms: 75% rated their libido as poor or terrible76% rated their energy level as poor or terrible66% rated their strength and/or endurance as poor or terrible62% rated their enjoyment of life as poor or terrible46% rated their happiness level as poor or terrible72% rated the strength of their erections as somewhat or extremely weak53% rated their work performance over the past 4 weeks as poor or terrible59% fall asleep at least 3-4x/week after eating dinner72% rated their sports ability over the past 4 weeks as poor or terrible Together, this data reflects a broader pattern of symptoms often associated with low testosterone, highlighting the need for accessible solutions to support men experiencing these challenges. View the infographic for a detailed results breakdown. "This data reinforces the necessity for greater awareness and resources to address men's health concerns, particularly testosterone deficiency, which can profoundly affect physical and emotional well-being," said Amit Shah, Chief Operating Officer of Marius Pharmaceuticals. "At Marius, we are committed to providing safe, effective options for managing low testosterone with products like KYZATREX." KYZATREX is an FDA-approved oral form of testosterone replacement therapy (TRT) indicated for adult males experiencing low or no testosterone due to certain medical conditions. A six-month clinical trial demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.1,2* *Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.1 Testosterone deficiency, also known as hypogonadism, affects millions of men worldwide and is associated with various chronic conditions, including obesity, diabetes and depression.3,4 As the global demand for men’s health solutions grows, Marius Pharmaceuticals continues to prioritize patient-centered therapies, empowering men to take control of their health and well-being. For more information on KYZATREX, visit www.kyzatrex.com. About Marius PharmaceuticalsMarius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's 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® 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 visiting www.mariuspharma.com. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. References: KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.“Hypogonadism in Men.” Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.Shores MM, Sloan KL, Matsumoto AM, et al. Increased incidence of diagnosed depressive illness in hypogonadal older men. Arch Gen Psychiatry. 2004;61(2):162–167. Media Contact Marius PharmaceuticalsLilly Washburnlilly@mariuspharma.com

Clinical Result

13 Nov 2024

·www.businesswire.com

Havah Therapeutics Granted Additional Patent Protection for T+Ai™

BOULDER, Colo.--( BUSINESS WIRE )--Havah Therapeutics today, announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (US Patent No. 12,128,055) for its innovative T+Ai combination therapy—a novel composition of testosterone and anastrozole in a long-acting, slow-release subcutaneous implant. “Our new patent for T+Ai is a critical milestone as we advance through the ongoing RECAST DCIS Phase 2 trial,” said Matthew Brewer, CEO of Havah Therapeutics. “With a sustained-release profile that shows significant therapeutic promise based on our previous clinical data, we are one step closer to bringing this innovative product to patients.” The newly granted patent for T+Ai further strengthens Havah Therapeutics’ intellectual property portfolio, securing protection for its innovative subcutaneous extended-release therapy. T+Ai was developed to provide a long-term, safe, and well-tolerated solution for hormonal modulation with a particular focus on breast cancer prevention and treatment. This unique formulation of testosterone and anastrozole is designed to address critical needs in oncology, offering potential in the early treatment of estrogen receptor-positive (ER+) cancers to reduce the risk of developing resistance to hormonal therapies. Currently in a Phase 2 platform study, T+Ai’s patented properties include rapid early induction of testosterone conversion to dihydrotestosterone within tissue, potentially enhancing anti-proliferative and anti-cancer effects, especially in women with high mammographic breast density. About Havah Therapeutics Havah Therapeutics is developing a novel therapeutic implant for treating hormonally sensitive cancers and other breast conditions. This groundbreaking method relies on stimulating (agonizing) the androgen receptor in breast tissue, utilizing natural hormonal mechanisms to treat women safely and with greatly reduced side effects. The product, T+Ai™ , is a combination of two registered agents (testosterone and anastrozole, a low dose aromatase inhibitor) that when dosed, provides three months of continuous medication enabling a superior product profile for compliance, safety and efficacy. Havah Therapeutics is currently participating in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. For more information, visit www.havahtx.com .

Phase 2

07 Nov 2024

·www.prnewswire.com

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

SALT LAKE CITY, Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option. The Company has completed labeling studies such as a food effect study and PK profiling in women with PPD, and is targeting NDA submission for LPCN 1154 by the end of 2024. In October, Lipocine announced positive results from a quantitative electroencephalogram (qEEG) study conducted in healthy subjects administered single doses of LPCN 1154. The results indicated robust central nervous system (CNS) activity of LPCN 1154, with concentration- and time-dependent post-dose changes in qEEG. The study confirmed GABAA positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications. LPCN 2401 for obesity management LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen. In October, Lipocine hosted a virtual key opinion leader (KOL) event on LPCN 2401. The event highlighted positive data from the Phase 2 study of LPCN 2401 and the data support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation. Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center) discussed the unmet needs and current treatment landscape in obesity management with a focus on fat loss and lean muscle mass preservation for patients on incretin therapies. A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring the Phase 2 data was presented by Dr. Greenway at the Obesity Society's Annual ObesityWeek® conference on November 5, 2024 in San Antonio, TX. Lipocine plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population. LPCN 1148 Management of Cirrhosis Lipocine is evaluating LPCN 1148 for the management of decompensated cirrhosis and has conducted a successful Phase 2 study that met its primary endpoint. The Company plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148. TLANDO® In October, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. In September, Lipocine signed an exclusive distribution and license agreement with SPC Korea to commercialize TLANDO in South Korea. The company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our remaining pipeline candidates. Third Quarter Ended September 30, 2024 Financial Results Lipocine reported a net loss of $2.2 million, or ($0.44) per diluted share, for the third quarter ended September 30, 2024, compared with a net loss of $6.7 million, or ($1.27) per diluted share, for the quarter ended September 30, 2023. There were no revenues recorded during the third quarter ended September 30, 2024. In the third quarter of 2023, the company recorded a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million related to the termination of the Antares License Agreement. Research and development expenses were $1.6 million and $2.9 million, respectively, for the quarters ended September 30, 2024 and 2023. The decrease was a result of a decrease in TLANDO related costs, a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, and a decrease in costs related to LPCN 1154 clinical studies, offset by increases in personnel related costs and other research and development related costs and supplies. General and administrative expenses were $1.0 million in each of the quarters ended September 30, 2024 and 2023. As of September 30, 2024, Lipocine had $19.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. Nine Months Ended, September 30 2024, Financial Results Lipocine reported a net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024, compared with a net loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023. Revenues for the nine-month period ended September 30, 2024 were $7.7 million, primarily consisting of licensing revenue received from our Verity License Agreement, in addition to TLANDO royalty revenue of $206,000. During the nine months ended September 30, 2023, the company recognized a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million relating to the termination of the Antares License Agreement offset by licensing revenue of approximately $55,000 for payments received related to the Spriaso license agreement. Research and development expenses were $6.3 million and $8.5 million, respectively, for the nine months ended September 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, a decrease in TLANDO related costs, a decrease in personnel related costs, and a decrease in other research and development related costs. These decreases were offset an increase in costs related to the LPCN 1154 clinical studies. General administrative expenses were $4.1 million and $3.8 million respectively, for the nine months ended September 30, 2024 and 2023. The increase in general and administrative expenses was a result of increases in business development expenses, corporate legal fees and director fees, offset by decreases in corporate insurance expense, professional fees, other administrative consulting fees, personnel related costs, and travel related costs. For more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding development and commercialization of TLANDO and TLANDO XR by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultLicense out/inPhase 2Drug ApprovalFinancial Statement

100 Deals associated with Testosterone

External Link

KEGG	Wiki	ATC	Drug Bank
D00075	Testosterone	G03BA03	DB00624

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
secondary testicular failure	US	Endo Operations Ltd.	29 Dec 2010
Sexual Dysfunctions, Psychological	EU	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	EU	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	IS	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	IS	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	LI	Teva NI Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	LI	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	NO	Warner Chilcott Ltd.	28 Jul 2006
Sexual Dysfunctions, Psychological	NO	Teva NI Ltd.	28 Jul 2006
Low testosterone levels	US	Endo Operations Ltd.	31 Oct 2002
Hypogonadism	US	AbbVie, Inc.	29 Sep 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Klinefelter Syndrome	Phase 3	US	Amneal Intermediate, Inc.	01 Mar 2014
Testosterone deficiency	Phase 3	US	Amneal Intermediate, Inc.	01 Mar 2014
Testosterone deficiency	Phase 3	US	AbbVie, Inc.	01 Mar 2014
Arthralgia	Phase 3	US	National Cancer Institute	01 Aug 2013
Arthralgia	Phase 3	PR	National Cancer Institute	01 Aug 2013
Breast Cancer	Phase 3	US	National Cancer Institute	01 Aug 2013
Breast Cancer	Phase 3	PR	National Cancer Institute	01 Aug 2013
Hot Flashes	Phase 3	US	National Cancer Institute	01 Aug 2013
Hot Flashes	Phase 3	PR	National Cancer Institute	01 Aug 2013
Musculoskeletal Abnormalities	Phase 3	US	National Cancer Institute	01 Aug 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Primary Malignant Liver Neoplasm testosterone \| estradiol \| tumor necrosis factor receptor superfamily member 9 (TNFRS9) ... View more	-	TESTOSTERONE (Estradiol levels)	afmkzdggoz(bzsilzinug) = dlahgsegnn wuiyryhsob (zsqerehuje ) View more	Positive	13 Oct 2024
NCT05781685 (CTgov)	Early Phase 1	Acute Pain	20	Testosterone+Placebo Syrup (Testosterone)	wsduhyoxix(xfkfhbaecq) = oglppnumnr mpepiagxfx (ocalbmlybt, dqfuesftkq - keydmcucvi) View more	-	05 Aug 2024
				Testosterone+Placebo Syrup (Placebo)	wsduhyoxix(xfkfhbaecq) = wcuitrazzr mpepiagxfx (ocalbmlybt, dvdngkjrju - nzccfrjjvj) View more
ADA2024	Not Applicable	Obesity	-	Testosterone Replacement Therapy (TRT)	xtutgyaknf(ljyvnstnjb) = vlyvbvdviy jrbnedkclf (ffsfiweiyv ) View more	-	14 Jun 2024
ATS2024	Not Applicable	Acute Lung Injury	-	Anabolic Testosterone Isocaproate	khyuaxoetl(jjbgibqwmy) = Our patient is a 46-year-old smoker who presented with two days of progressively dyspnea preceded by two weeks of cough. His history was significant for polysubstance use disorder. In the emergency department, he was found to be hypoxic to 60% with diffuse crackles and expiratory wheezes on exam, so he was given a dose of systemic steroids and started nebulizers. Chest radiograph and chest CT scan (figure 1) showed diffuse bilateral ground glass opacities. His respiratory status deteriorated rapidly, and he was intubated, then he was ultimately admitted to the MICU for acute hypoxemic respiratory failure. All infectious work-up including sputum culture and rapid respiratory pathogen PCR were negative. Over the next three days, he continued to have higher oxygen requirements, so empiric steroids were given then flexible bronchoscopy was performed with BAL demonstrating eosinophils of 14%, and lymphocytes of 3%. BAL bacterial and fungal cultures were negative. He was started on IV methylprednisolone, responded very well and after 3 days he was extubated. Following extubation, he reported using non-prescribed anabolic testosterone isocaproate for bodybuilding over the past several months and had three similar presentations with respiratory distress with chest CT also showing bilateral ground glass opacities and negative infectious workup. In all of them, he exhibited clinical improvement following each of these presentations with normal chest radiographs in between. He was followed in pulmonary clinic and was advised to stop using anabolic steroids with no recurrence to date. nmbvhtrjyn (waplplypgg )	-	19 May 2024
ISN WCN2024	Not Applicable	Infarction	-	Rivaroxaban 15mg/day	erqvgyruew(rglmcjbnlh) = wmxofwqzum gtlykazdrz (dwlilwzoqq )	-	01 Apr 2024
NCT03518034 (TRAVERSE, CTgov)	Phase 4	Hypogonadism \| Cardiovascular Diseases	5,246	AndroGel® (AndroGel 1.62%)	lpshblwiuj(sngcesgoum) = iifcndwweo wxzwqlcryx (vjuompmqgt, axdestvhfi - geodvmroix) View more	-	13 Mar 2024
				Placebo (Placebo)	lpshblwiuj(sngcesgoum) = ghvgfzhfhl wxzwqlcryx (vjuompmqgt, gwmhpblsfg - ssdtdpfypu) View more
NCT00467987 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2 \| secondary testicular failure \| Atherosclerosis ... View more	47	androgel (Androgel)	zereflwnpc(xknjmvibdb) = idwawlrfop fclauwafsb (ayloaummnl, rlhtwkfzvs - osyouffkmg) View more	-	06 Feb 2024
				placebo (Placebo)	zereflwnpc(xknjmvibdb) = btcvmremaq fclauwafsb (ayloaummnl, jsltxvvxxx - chnxrbltov) View more
NCT03518034 (TRAVERSE, Pubmed \| Br Dent J) Manual	Phase 4	Hypogonadism	5,204	Testosterone gel	bapatsgtrz(cfpbnxowpq) = qxqankiasr fgeimiazhf (tbyhigqfsb )	Negative	18 Jan 2024
				Placebo gel	bapatsgtrz(cfpbnxowpq) = hmxjcsfzkq fgeimiazhf (tbyhigqfsb )
NCT04439799 (CTgov)	Phase 4	Eunuchism	81	Testosterone Cypionate 200 Mg/ML (Testosterone Cypionate Group)	vuefhtgqzo(etweluivhl) = prxcjkmrjr ekerzvnwjr (roiedkdbfs, xtxyylzfbv - kinpholjhi) View more	-	13 Dec 2023
				Intranasal Testosterone (Natesto Group)	vuefhtgqzo(etweluivhl) = sxwccfaneu ekerzvnwjr (roiedkdbfs, aibxpqzbow - xgmsvvkmfp) View more
NCT01460654 (CTgov)	Phase 2	Hypogonadism \| Osteoporosis	44	Testosterone+Placebo Alendronate (Testosterone and Placebo Alendronate)	pqztvzlgds(xxqfgtiola) = oocbwrqwfi pqfwfufbbx (yqpmarogrf, iwewjamgvw - arnkluxrwl) View more	-	12 Oct 2023
				Alendronate+Placebo Testosterone (Alendronate and Placebo Testosterone)	pqztvzlgds(xxqfgtiola) = jkyoeepibb pqfwfufbbx (yqpmarogrf, iouvgigcuv - xevvzkexhm) View more

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