A multicenter, prospective, observational, single arm real-world study on the efficacy of levonorgestrel in the treatment of functional constipation patients

Start Date31 Aug 2025

Sponsor / Collaborator-

NCT06883890

/ Not yet recruitingPhase 2IIT

Extended LH Administration (ELHA), a Strategy to Increase the Pool of Recruitable Antral Follicles: a Multicentric Randomized Trial

Luteinizing hormone (LH) plays an important role in follicular development, especially in the later stages of folliculogenesis. Theca interstitial cells and, later, granulosa cells express high concentrations of receptors for LH (LH-R). LH modulates the progressive remodeling and growth of the follicle .
New evidence points to a role for LH in promoting ovarian follicle growth and maturation, even at very early stages of folliculogenesis. Studies analyzing LH-R expression profiles in the ovary have shown that LH-R is moderately expressed even in the smallest follicles, during what is known as the gonadotropin-independent phase . Immunohistochemical studies that examined the localization of LH-R in human follicles through different stages of follicular development reveal that LH-R is expressed by granulosa cells and some thecal cells in small pre-antral follicles LH promotes the transition of follicles to the antral stage, thus leading to an increase in functional ovarian reserve. Early follicular stages, particularly those between the primordial and pre-antral stages, are critical as they regulate the rate of follicle recruitment. The potential roles of LH in the early follicular phase were analyzed in a prospective, randomized multicenter study using a sequential approach to stimulation with recombinant human r-LH, followed by r-FSH, in women in hypogonadotropic hypogonadism because they were profoundly down-regulated by the administration of depo agonist GnRH analog. LH treatment was associated with an increase in small antral follicles before FSH stimulation and a higher number of normally fertilized embryos. In addition, AMH hormone was found to be significantly increased in both groups during the week prior to FSH stimulation These results seem to indicate that, if the reduction in the number of antral follicles is not due to a decrease in the number of primordial follicles, but to a slowing of progression, as in the case of women with long-standing hypothalamic amenorrhea, there may be room for a therapeutic approach. This is with the aim of improving the response to ovarian stimulation of the aforementioned patients who present with anovulatory cycles and in a condition of hypogonadotropic hypogonadism.
A recent case series described two patients suffering from hypothalamic amenorrhea with very low levels of endogenous gonadotropins, and ovulatory factor infertility. These patients were treated with exogenous LH for one to two months (prolonged administration of LH). Increased levels of both AMH and AFC were demonstrated, and they responded adequately to ovarian stimulation.
The purpose of this multicenter prospective randomized study follows recent publications confirming the implementation of ovarian reserve by supplementation with pretreatment with r-LH, a drug already on the market and routinely used in conventional controlled ovarian stimulation protocols.
The aim is to confirm that pretreatment with rhLH at a dose of 185.5 IU/day for 60 days can improve ovarian reserve, as indicated by increased baseline AMH and AFC, compared with no pretreatment. The primary outcome is serum AMH value after treatment with r-LH and without.
The planned duration of the study is 18 months, and a total of 84 patients are to be recruited. Patients will be randomized into two groups: group A who will receive pre-treatment with r-LH 185.5IU/day for 60 days and group B who will not receive pre-treatment.
Patients will have a monitoring visit every two weeks for the duration of treatment, during which an ultrasound and blood sampling will be performed to evaluate the hormonal picture. Following pretreatment, a visit of with assessment of serum AMH and AFC value will be performed and the planned IVF cycle will be started. This will be followed by an additional final follow-up visit to collect obstetric and newborn outcomes that will be conducted by telephone

Start Date17 Mar 2025

Sponsor / Collaborator

Azienda Ospedaliero-Universitaria di Modena

NCT06571214

/ Not yet recruitingPhase 4IIT

An Exploratory, Randomized, Open-label, Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.
After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

Start Date01 Sep 2024

Sponsor / Collaborator

Nanjing University

100 Clinical Results associated with Lutropin Alfa

100 Translational Medicine associated with Lutropin Alfa

100 Patents (Medical) associated with Lutropin Alfa

320

Literatures (Medical) associated with Lutropin Alfa

26 Sep 2025·MEDICINE

How FSH and LH analogs affect fertility hormone results?

Article

Author: Gonel, Ataman ; Ersoy, Ebru

Infertility is defined as the inability of a couple to achieve pregnancy within a certain period despite regular sexual intercourse. With technological advances, infertility treatments have also advanced, and assisted reproductive technologies have become increasingly widespread. In this study, the potential interference effects of different gonadotropin preparations used during controlled ovarian stimulation in in vitro fertilization treatment on hormone levels were experimentally investigated. The effects of urine-derived (menotropin and urofollitropin) and recombinant (folitropin and folitropin + lutropin) gonadotropin preparations on the hormone levels were evaluated. Interference effects on follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, testosterone, thyroid-stimulating hormone, free T3, and free T4 hormone levels were analyzed using immunoassay techniques. The results showed significant deviations, especially in the FSH and LH tests, whereas the interference levels varied among the different preparations. The highest interference was observed in the FSH assays, with deviations reaching up to 292,138%. Significant differences were also observed in estradiol and thyroid hormones (free T3 and free T4). These findings suggest that gonadotropin drugs containing high concentrations of FSH and LH may interfere with routine immunoassay-based hormone tests, leading to errors in clinical interpretation. This study emphasizes the need for careful interpretation of hormone assays in patients undergoing in vitro fertilization treatment, and the importance of considering possible interference effects.

01 Jun 2024·Reproductive biomedicine online

Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35–40 years

Article

Author: Krussel, Jan-Steffan ; Bielfeld, Alexandra P ; Fischer, Robert ; Chuderland, Dana ; Verpillat, Patrice ; Lispi, Monica ; Schwarze, Juan-Enrique ; Hayward, Brooke ; D'Hooghe, Thomas

RESEARCH QUESTION:

According to real-world data, is recombinant human FSH (r-hFSH) combined with recombinant human LH (r-hLH) or r-hFSH alone more effective for women of advanced maternal age (AMA) in terms of live birth?

DESIGN:

Non-interventional study comparing the effectiveness of r-hFSH and recombinant r-hLH (2:1 ratio) versus r-hFSH alone for ovarian stimulation during ART treatment in women aged 35-40 years, using real-world data from the Deutsches IVF-Register.

RESULTS:

Overall clinical pregnancy (29.8%, 95% CI 28.2 to 31.6 versus 27.8%, 95% CI 26.5 to 29.2) and live birth (20.3%, 95% CI 18.7 to 21.8 versus 18.0%, 95% CI 16.6 to 19.4) rates were not significantly different between the combined r-hFSH and r-hLH group and the r-hFSH alone group (P = 0.269 and P = 0.092, respectively). Treatment effect was significantly higher for combined r-hFSH and r-hLH compared with r-hFSH alone for clinical pregnancy (33.1%, 95% CI 31.0 to 35.0 versus 28.5%, 95% CI 26.6 to 30.4; P = 0.001, not adjusted for multiplicity) and live birth (22.5%, 95% CI 20.5 to 24.2 versus 19.4%, 95% CI 17.6 to 20.9; P = 0.014, not adjusted for multiplicity) in a post-hoc analysis of women with five to 14 oocytes retrieved (used as a surrogate for normal ovarian reserve), highlighting the potential benefits of combined r-hFSH and r-hLH for ovarian stimulation in women aged 35-40 years with normal ovarian reserve.

CONCLUSIONS:

Women of AMA with normal ovarian response benefit from treatment with combined r-hFSH and r-hLH in a 2:1 ratio versus r-hFSH alone in terms of live birth rate. The effectiveness of treatments is best assessed by RCTs; however, real-world data are valuable for examining the effectiveness of fertility treatment, especially among patient groups that are not well represented in clinical trials.

01 Feb 2024·Expert opinion on drug delivery

Dose accuracy of the follitropin alfa pen injector 2.0, the follitropin alfa:lutropin alfa 2:1 combination pen injector 2.0 and the choriogonadotropin alfa pen injector 1.0 used for fertility treatment

Article

Author: Michalet, Damien ; Cottell, Evelyn ; Araujo, Thiago Dantas ; Lispi, Monica ; Gleixner, Ralf ; D’Hooghe, Thomas ; Longobardi, Salvatore

BACKGROUND:

This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors.

RESEARCH DESIGN AND METHODS:

Set doses (V_set) for three dose dial settings (minimum dose [V_min], midpoint dose [V_mid] and maximum dose [V_max] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single V_set for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed. Last dose administered by the multi-dose device was assessed for the 900 IU, 450 IU, 300 IU and 150 IU follitropin alfa, and the 900:450 IU, 450:225 IU and 300:150 IU follitropin alfa:lutropin-alfa 2:1 combination pen presentations.

RESULTS:

Dose accuracy tests for V_min, V_mid and V_max for the follitropin alfa and the follitropin alfa:lutropin-alfa 2:1 combination pen injectors, and last dose administered, were within acceptable limits according to ISO 11,608-1:2012/2014. Dose accuracy tests for the single use/single dose device classification and the single use/variable dose device classification of the choriogonadotropin alfa pen injector were also within the acceptable limits, according to ISO 11608-1:2000/2014.

CONCLUSIONS:

The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses.

News (Medical) associated with Lutropin Alfa

20 Oct 2025

·www.pharmaceutical-technology.com

Infertility treatment heads first drugs on FDA’s new priority review scheme

Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. kemalbas via GettyImages. The US Food and Drug Administration (FDA) has selected the first products to be included on the Commissioner’s National Priority Voucher (CNPV) pilot programme. A total of nine drug candidates have joined the scheme launched in June 2025 , which will see its developers receive a voucher that will significantly expedite their path to approval. The group is headed by Merck’s Pergoveris (follitropin alfa/lutropin alfa), which is already approved in Europe, for the treatment of infertility. President Donald Trump specifically identified Pergoveris’ inclusion, touting the drug’s potential to offer a cheaper option to US patients. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly,” Trump said during an IVF news conference at the White House. Trump was likely referring to Gonal-f, made by Merck’s US and Canadian healthcare business EMD Serono. Gonal-f generated global sales of €833m in 2024. The pharma company plans to use its CNPV to file for FDA approval of its new drug, which it disclosed while announcing a broader deal with the US government to expand fertility access treatment. Elsewhere on the list, candidates being developed for hearing and vision loss have been included in the form of Regeneron’s gene therapy DB-OTO and Dompé Farmaceutici’s Oxervate (cenegermin-bkbj), respectively. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Sanofi’s teplizumab, which is already FDA-approved to delay the onset of stage 3 type 1 diabetes, has been included on the list. The agency said it was selected for “type 1 diabetes,” hinting that the review could be for a broader label approval. Revolution Therapeutics’ RMC-6236, in development for the treatment of pancreatic cancer, and Disc Medicine’s porphyria therapy bitopertin round off the list of products for specific diseases. The FDA selected cytisinicline for nicotine vaping addiction, while ketamine and Augmentin XR were chosen to boost domestic manufacturing of anaesthesia and antibiotics, respectively. The CNPV programme is the latest move by the Trump administration to bolster its pharmaceutical armoury and incentivise the development of new drugs specifically for Americans . Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. Therapies need to address a health crisis in the country, produce an innovative cure for American patients, meet public health needs, or increase domestic drug manufacturing as a national security issue. In its statement sharing the first batch of recipients, the FDA said that each product has significant potential to address one or more of these major national priorities. The agency stated that it would likely add another group of CNPV recipients in the coming months. Companies with a product in the programme will receive a decision within 1-2 months, compared to the usual 10-12 months, following filing of a complete application for a drug or biologic. Sponsors will also be able to undertake enhanced feedback with FDA staff during development and the review window. “One of our core goals is to deliver more cures and meaningful treatments – especially ones that have an outsized impact on our most pressing national priorities. We must modernise the review process and try new approaches to meet the needs of the American people,” said FDA commissioner Marty Makary. While the CNPV pilot begins its journey in the US regulatory landscape, experts have been concerned that its activity could take attention away from similar programmes that incentivise rare diseases. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Drug ApprovalPriority Review

12 Apr 2016

·medcitynews.com

Morning Read: CMS has a new primary care initiative to give control back to the doctors

TOP STORIES The Centers for Medicare and Medicaid Services just announced a new, five-year primary care initiative meant to allow physicians to care for Medicare patients the way they want. The program, called the Comprehensive Primary Care Plus model, will be deployed in up to 20 regions and can include up to 5,000 practices – impacting more than 20,000 providers. –Healthcare Dive Intel healthcare maven Eric Dishman has been cherrypicked by the NIH to head up its Precision Medicine Intiative Cohort Program – overseeing the Obama-driven effort to sequence the genomes of one million Americans. –Fortune LIFE SCIENCES Intellia Therapeutics, one of the few biotech players using the powerful CRISPR-Cas9 technology to develop medicines, filed an IPO. This comes right on the heels of a $75 million deal with Regeneron Pharmaceuticals. –Xconomy Also on the IPO docket: North Carolina’s Viamet Pharmaceuticals, which is developing anti-fungal drugs, filed paperwork with the SEC to complete an initial public offering. This is its second effort at going public – it planned to raise $75 million in an IPO in 2014, but raised $60 million in a private placing instead. –Triangle Business Journal The Food and Drug Administration has withdrawn the approval of EMD Serono’s infertility drug Luveris, because the company didn’t run a post-market study that was required as a condition of its approval. –Regulatory Focus Halyard Health – formerly Kimberly-Clark Health Care – just acquired Corpak MedSystems for $174 million, scooping up its broad portfolio of enteral access devices. –Sonoran Weekly Review Celgene is paying out $50 million to Juno Therapeutics as an option of its CD19 CAR-T program. This is linked to its 10-year, $1 billion collaboration with Juno that was inked last summer, placing Celgene at the forefront of reengineered T-cell technology. –FierceBiotech The FDA has approved AbbVie’s Venclexta, a drug that treats chronic lymphocytic leukemia in a subset of patients that have a chromosomal abnormality called 17p deletion. –FDA PAYERS-PROVIDERS A Medicare proposal to test out new ways to pay for chemotherapy and other drugs has enraged doctors, who are calling for the Obama administration to call it quits with the experiment. –Associated Press TECHNOLOGY John Glaser of Cerner says that analytics, big data and the Internet of Things are highly promising in improving how patients receive care. He emphasized, however, that that improvement doesn’t necessarily require new technology, but can stem from optimizing tech investments that are already in place. –HealthcareIT News Teladoc has shown impressive growth: It has completed 240,000 telemedicine visits during the first quarter of the year – up 61 percent from 149,000 visits during the same period last year. –MobiHealthNews POLITICS The board of Valeant Pharmaceuticals has written a letter to its outgoing CEO, Michael Pearson, urging him to comply with a Congressional subpoena. He was supposed to be deposed April 6, but didn’t show up – which has led the U.S. Senate Special Committee on Aging to decide whether they’ll begin contempt proceedings against Pearson. This news sent Valeant’s stock down 7 percent. –Business Insider A LITTLE BIT EXTRA Scientists have developed a snazzy new way to organize the tree of life – expounding on the deep evolutionary relationships between flora, fauna and microbiota. –Nature

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100 Deals associated with Lutropin Alfa

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R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Infertility, Female	Australia	Merck Healthcare Pty Ltd.	24 Mar 2003
Follicle stimulating hormone deficiency	European Union	Merck Europe BV	29 Nov 2000
Follicle stimulating hormone deficiency	Iceland	Merck Europe BV	29 Nov 2000
Follicle stimulating hormone deficiency	Liechtenstein	Merck Europe BV	29 Nov 2000
Follicle stimulating hormone deficiency	Norway	Merck Europe BV	29 Nov 2000
Luteinizing hormone deficiency	European Union	Merck Europe BV	29 Nov 2000
Luteinizing hormone deficiency	Iceland	Merck Europe BV	29 Nov 2000
Luteinizing hormone deficiency	Liechtenstein	Merck Europe BV	29 Nov 2000
Luteinizing hormone deficiency	Norway	Merck Europe BV	29 Nov 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility	Phase 3	United Arab Emirates	Merck KGaA	01 May 2012
secondary testicular failure	Phase 3	China	Merck KGaA	01 Feb 2004
Ovarian Stimulations	Phase 2	Spain	Merck KGaA	07 Dec 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01112358 (CTgov)	Phase 2	Ovarian Stimulations	58	Analogous GnRH antagonist+r-hCG+progesterone+r-hLH+r-FSH (r-FSH + r-hLH)	ocpqoqwidm(fauscrscvy) = rijsrygznp bifmhfcbxr (bgcfudfmhv, 5.3) View more	-	30 Jul 2018
				Analogous GnRH antagonist+r-hCG+progesterone+r-FSH (r-FSH)	ocpqoqwidm(fauscrscvy) = umonpxzimn bifmhfcbxr (bgcfudfmhv, 3.1) View more
NCT01110707 (CTgov)	Phase 2	Infertility	131	Recombinant human follicle stimulating hormone (r-hFSH)+Recombinant human luteinizing hormone (r-hLH) (r-hFSH + r-hLH)	oodrxezpqf(hiordweopn) = amngiupsbj usgxamtttk (eyumfmguep, 4.1) View more	-	27 Mar 2018
				Recombinant human luteinizing hormone (r-hLH) (r-hFSH Alone)	oodrxezpqf(hiordweopn) = euvrkyxnni usgxamtttk (eyumfmguep, 4.8) View more
NCT01497197 (CTgov)	Phase 3	Follicle stimulating hormone deficiency \| Infertility	174	Luveris+Gonal-f (Gonal-f®+Luveris)	yonkjyyvob(mtlhcinlpn) = kthvjyylsw hfghpnzqzr (jmhfmzdene, 6.54) View more	-	09 Nov 2015
				Luveris+Gonal-f (Gonal-f® Followed by Luveris)	yonkjyyvob(mtlhcinlpn) = ybrcpmmuam hfghpnzqzr (jmhfmzdene, 5.77) View more
NCT02108223 (LH, CTgov)	Phase 4	Infertility	137	r-FSH+Gonal-f (Fix Dose r-FSH (Gonal-f))	dpdevmjwky(jirildbpvt) = uxwnhkenec fgsskqjbvp (jsjzpxazsj, 4) View more	-	19 Aug 2014
				r-LH supplementation (r-LH Supplementation to r-FSH)	dpdevmjwky(jirildbpvt) = rirohgmtqp fgsskqjbvp (jsjzpxazsj, 3.4) View more
NCT01079949 (CTgov)	Phase 2	Infertility	93	GnRH antagonist+Recombinant Human Choriogonadotropin (r-hCG)+r-hFSH	ttdlysvrxm(bcvuklexta) = tlvjjioikm ydujpdlxfc (atgnobheuu, 5.2) View more	-	20 Feb 2013

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