Clinical trials: Gonadotropins
Infertility
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted…
- Trial name
- NCT07340827
- Testing
- Follitropin alfa/lutropin alfa (MBJ-0011), hMG, Cetrorelix acetate
- Where
- 21 sites in Japan
- Volunteers
- 266 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Infertility, Ovulation Induction
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory…
- Trial name
- NCT01185782
- Testing
- Gonalef® (Follitropin alfa), Purified pituitary gonadotropin (Fertinorm-P®)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
Prostate Cancer
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.
- Trial name
- NCT00415246
- Testing
- Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
- Where
- 31 sites in Belgium, France and 6 more
- Volunteers
- 100 people
- Sponsor
- Ipsen
Infertility, Female
Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment
The purpose of this retrospective observational study is to describe the treatment patterns with MENOPUR and to understand the clinical impact for patients that underwent infertility treatment under real-world setting.
- Trial name
- NCT04814940
- Testing
- MENOPUR Cohort
- Where
- Israel
- Sponsor
- Ferring Pharmaceuticals
Endometriosis
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
- Trial name
- NCT01395940
- Testing
- KLH-2109
- Where
- Japan
- Volunteers
- 20 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Infertility
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing…
- Trial name
- FASHION (NCT02449889)
- Testing
- highly purified human chorionic gonadotropin, recombinant human chorionic gonadotropin
- Where
- Brazil
- Volunteers
- 176 people
- Sponsor
- Ferring Pharmaceuticals
Prostate Cancer
Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy
The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.
- Trial name
- PRISME (NCT03516110)
- Testing
- Data collection
- Where
- France
- Volunteers
- 831 people
- Sponsor
- Ipsen
Amenorrhea, Fertility
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses.
- Conditions
- Amenorrhea, Fertility, Infertility
- Trial name
- NCT07152730
- Testing
- Lutrepulse
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Endometriosis
A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets…
- Trial name
- NCT02807363
- Testing
- Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID, Leuprolide Depot
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Enteris BioPharma Inc.
Fertility
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single…
- Trial name
- NCT07269327
- Testing
- Desogestrel and ethinylestradiol fixed dose combination, Follitropin alfa/lutropin alfa
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Polycystic Ovary Syndrome
A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international…
- Trial name
- ARTIST (NCT02607293)
- Testing
- Gonal-f®, Long GnRH agonist, GnRH antagonist
- Where
- Germany
- Volunteers
- 1,064 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
In Vitro Fertilization, Controlled Ovarian Stimulation
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation.
- Trial name
- NCT04122729
- Where
- 12 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Angelini Farmacéutica
IVF, Infertility
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH…
- Trial name
- STORM (NCT05873725)
- Testing
- Follitropin delta
- Where
- Canada
- Volunteers
- 118 people
- Sponsor
- Clinique Ovo
Folliculogenesis
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on…
- Trial name
- NCT01403038
- Testing
- Elagolix
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Endometriosis
A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
- Trial name
- NCT01533532
- Testing
- KLH-2109
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Precocious, Leuprolide Acetate
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
- Conditions
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa)
- Trial name
- NCT00667446
- Testing
- Leuprolide Acetate 3 Month Depot
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 72 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Endometriosis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
- Trial name
- ELARIS EM-I (NCT01620528)
- Testing
- elagolix
- Volunteers
- 872 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Puberty; Precocious, Central
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
- Trial name
- NCT05493709
- Testing
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- Where
- 41 sites in United States, China and 2 more
- Volunteers
- 94 people
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Preterm Delivery
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening…
- Trial name
- NCT01009723
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Esoterix Genetic Laboratories, LLC