Clinical trials: Gonadotropins
BRCA1 Mutation, Breast Cancer
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
- Trial name
- NCT00700778
- Testing
- recombinant human chorionic gonadotropin, microarray analysis, immunohistochemistry staining method
- Where
- 3 sites in United States, Austria
- Volunteers
- 2 people
- Sponsor
- Fox Chase Cancer Center
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
Healthy
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.
- Trial name
- NCT02432261
- Testing
- Nestorone® /testosterone gel, Testosterone only gel
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Kimberly Myer
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.
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
Controlled Ovarian Stimulation, Infertility
Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during…
- Trial name
- NCT01339299
- Testing
- recombinant luteinizing hormone (r-LH), recombinant human chorionic gonadotropin (r-hCG)
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Regionshospitalet Viborg, Skive
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)
Infertility, Subfertility
Effect of hCG on Receptivity of the Human Endometrium
Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is fertilized by sperm outside the body), ovarian…
- Trial name
- NCT01786252
- Testing
- human chorionic gonadotropin (hCG)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Michigan State University
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
Graft vs Host Disease
Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD
The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or…
- Trial name
- NCT02525029
- Testing
- Pregnyl®
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
This is a randomized, double-blind, single center clinical trial study to compare oocyte competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG)…
- Trial name
- NCT02310919
- Testing
- Low dose hCG plus FSH co-trigger, Standard dose of hCG
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Premenopause, Healthy
Effect of Race on Gonadotropin Responses
The purpose of this study is to attempt to determine why estrogen levels are increased in African-American women as compared to Caucasian women by evaluating estrogen feedback on the brain.
- Trial name
- NCT00455962
- Testing
- Estradiol steroid infusion, Progesterone steroid infusion
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital