Clinical trials: Gonadotropins
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
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
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.
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)
Central Precocious Puberty
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty.
- Trial name
- NCT01467882
- Testing
- Triptorelin
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 44 people
- Sponsor
- Debiopharm International SA
BPH
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with…
- Trial name
- NCT00527488
- Testing
- Degarelix
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- Ferring Pharmaceuticals
Endometriosis
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
- Trial name
- NCT01760954
- Testing
- Elagolix
- Volunteers
- 506 people
- Sponsor
- AbbVie
Infertility
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation…
- Trial name
- MEGASET HR (NCT02554279)
- Testing
- menotropin, recombinant FSH
- Where
- 35 sites in United States
- Volunteers
- 620 people
- Sponsor
- Ferring Pharmaceuticals
Anovulation, Oligo-ovulation
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU)…
- Conditions
- Anovulation, Oligo-ovulation, Hypothalamic-pituitary Dysfunction, Polycystic Ovarian Syndrome
- Trial name
- NCT01653743
- Testing
- MSJ-0011, urinary hCG (u-hCG), Follitropin alpha
- Where
- 6 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Puberty, Precocious
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys.
- Trial name
- BATT (NCT00094328)
- Testing
- Bicalutamide, Anastrozole
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Precocious Puberty, Central
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
- Trial name
- NCT02452931
- Testing
- Leuprolide Acetate 45 mg
- Where
- 20 sites in United States, Argentina and 4 more
- Volunteers
- 64 people
- Sponsor
- Tolmar Inc.
Infertility, Female
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
- Trial name
- NCT00434122
- Testing
- Degarelix mid-luteal, 2.5 mg
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Infertility
MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles…
- Trial name
- MEGASET (NCT00884221)
- Testing
- Highly purified menotrophin, Recombinant FSH
- Where
- 25 sites in Belgium, Czechia and 5 more
- Volunteers
- 749 people
- Sponsor
- Ferring Pharmaceuticals
Salivary Gland Neoplasms
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or…
- Trial name
- YATAGARASU (NCT04325828)
- Testing
- Apalutamide, GnRH Agonist
- Where
- 7 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Janssen Pharmaceutical K.K.
Stroke
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
The purpose of this study is: To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
- Trial name
- REGENESIS-LED (NCT00938314)
- Testing
- human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 96 people
- Sponsor
- Stem Cell Therapeutics Corp.
Hypogonadism, Hypogonadotropic Hypogonadism
A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)
This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG…
- Trial name
- NCT01709331
- Testing
- Corifollitropin alfa, hCG
- Volunteers
- 18 people
- Sponsor
- Organon and Co
Prostate Cancer
Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer
The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.
- Trial name
- NCT02135445
- Testing
- TAK-385, Degarelix
- Where
- 25 sites in United States, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Infertility
Rekovelle PK Trial in Chinese Women
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals.
- Trial name
- NCT04150861
- Testing
- Follitropin Delta
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals