26 results
To test the hypothesis that in women with unexplained recurrent miscarriages, progesterone started as soon as possible after a positive pregnancy test ) and continued to 12 weeks of gestation, compared to placebo, increases live births beyond 24…
To evaluate whether progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery. In addition to assess whether it is cost-effective to do so.
The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poorovarian response (POR) patients defined according to modified criteria set forth by the European Society of Human Reproduction and Embryology (…
To investigate the effect of various dose regimens of Cyclogest® on secretory transformation of the endometrium in comparison to Crinone® and placeboTo investigate single and multiple dose pharmacokinetics of Cyclogest®To investigate safety and…
The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed…
The aim of the study is to determine the efficacy and safety of BHR-100 i.v. progesterone infusion compared to placebo infusion, utilizing the GOS in severe traumatic brain injury patients (GCS 3-8), with the treatment administered continuously over…
Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial-
To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. Secondary objectives include safety and patient satisfaction, mood, and sleep.
The primary objective is to demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.
The primary objective of the study is to evaluate the safety, tolerability, PK, and PD of AL002 administered in single ascending doses in healthy participants and multiple doses in participants with mild to moderate AD.
The primary objectives of this add-on Phase 2 LTE study (see Table 1) are to evaluate the long-term safety and tolerability of IMP at three possible doses (ie, 15 mg/kg, 40 mg/kg, and 60 mg/kg) and to assess the effect of dose titration on the…
Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic [PK] and, if applicable,pharmacodynamic data) for use in pediatric subjects (age >=1 to <12 years)…
The primary objective of the study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
Analysis Study:To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.
Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review…
To compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
The primary objective of the study is to evaluate the efficacy of obinutuzumab(GA101) plus venetoclax (GVe) versus standard chemoimmunotherapy (BR/FCR)[concerning MRD negativity measured by flow cytometry in peripheral blood (PB)at month 15] and…
Primary ObjectiveThe primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.Secondary…
The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for progression free survival (PFS) at 12 months after stopping therapy (27 months after starting treatment) for…
Run-in Part (Part 1)Objectives Primary* Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults Secondary* Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in…