Clinical trials: Gonadal Disorders
Male Hypogonadism
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- NCT01403116
- Testing
- Oral testosterone undecanoate, topical testosterone gel
- Where
- 30 sites in United States, Germany
- Volunteers
- 325 people
- Sponsor
- Clarus Therapeutics, Inc.
Ovarian Neoplasms
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum…
- Trial name
- NCT01121406
- Testing
- Paclitaxel, Gemcitabine, Topotecan
- Where
- 31 sites in Belgium, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Boehringer Ingelheim
Ovarian Neoplasm, Fallopian Tube Neoplasms
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated…
- Conditions
- Ovarian Neoplasm, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- Trial name
- NCT05257408
- Testing
- Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2, Nab-paclitaxel 100 mg/m^2
- Where
- 116 sites in United States, Argentina and 12 more
- Volunteers
- 381 people
- Sponsor
- Corcept Therapeutics
Hypothalamic Obesity
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
- Trial name
- NCT04725240
- Testing
- Setmelanotide
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Progressive Metastatic Malignancies
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug.
- Trial name
- NCT00496860
- Testing
- ALT-801
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Altor BioScience
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a…
- Trial name
- NCT04045145
- Testing
- Crinecerfont
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT03257462
- Testing
- SPR001
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Spruce Biosciences
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
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Ovarian Cancer
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.
- Trial name
- NCT00866697
- Testing
- Pazopanib
- Where
- 318 sites in United States, Australia and 15 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals
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
Solid Tumor
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific…
- Trial name
- NCT03989115
- Testing
- RMC-4630, Cobimetinib, Drug: Osimertinib
- Where
- 24 sites in United States, South Korea
- Volunteers
- 113 people
- Sponsor
- Revolution Medicines, Inc.
Puberty, Precocious, McCune-Albright Syndrome
Faslodex in McCune-Albright Syndrome
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with…
- Trial name
- FMAS (NCT00278915)
- Testing
- Fulvestrant
- Where
- 16 sites in United States, France and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Hypogonadism
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation…
- Trial name
- NCT01084265
- Testing
- Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hypogonadism
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety…
- Trial name
- NCT00857454
- Testing
- Testosterone MD-Lotion
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- Eli Lilly and Company
Epithelial Ovarian Cancer
Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
- Trial name
- NCT00408603
- Testing
- Voreloxin Injection
- Where
- 20 sites in United States, Canada
- Volunteers
- 183 people
- Sponsor
- Sunesis Pharmaceuticals
Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
- Conditions
- Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
- Trial name
- NCT02711345
- Testing
- LTT462
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer, Pancreatic Cancer
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under…
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT04803305
- Testing
- PF-06946860
- Where
- 33 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Pfizer
Platinum Sensitive, BRCA Mutated
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with…
- Conditions
- Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy
- Trial name
- NCT01874353
- Testing
- Olaparib 300mg tablets
- Where
- 126 sites in United States, Australia and 15 more
- Volunteers
- 327 people
- Sponsor
- AstraZeneca
Ovarian Carcinoma, Breast Cancer
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to…
- Trial name
- NCT00679783
- Testing
- AZD2281
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- AstraZeneca