Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation

Reproductive Biology and Endocrinology

Volumn 13, Issue 1, 2015, Pages

  Lammerich, Andreas ^a   Mueller, Arnd ^a   Bias, Peter ^a  

^a TEVA PHARMACEUTICALS   (Israel)

Author keywords

Infertility; Pharmacokinetics; Recombinant human follicle stimulating hormone

Indexed keywords

FOLLITROPIN; GOSERELIN; ORAL CONTRACEPTIVE AGENT; RECOMBINANT FOLLITROPIN; UNCLASSIFIED DRUG; XM 17; GONADORELIN; RECOMBINANT PROTEIN;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOWN REGULATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; FEMALE; HEADACHE; HORMONAL REGULATION; HOT FLUSH; HUMAN; INJECTION SITE PAIN; LOWER ABDOMINAL PAIN; MASTALGIA; MAXIMUM PLASMA CONCENTRATION; METRORRHAGIA; NAUSEA; OPEN STUDY; OROPHARYNX PAIN; PHASE 1 CLINICAL TRIAL; SINGLE DRUG DOSE; ADOLESCENT; AGONISTS; CLINICAL TRIAL; COMPARATIVE STUDY; RANDOMIZED CONTROLLED TRIAL; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; CROSS-OVER STUDIES; FEMALE; FOLLICLE STIMULATING HORMONE, HUMAN; GONADOTROPIN-RELEASING HORMONE; GOSERELIN; HUMANS; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84952863268     PISSN: None     EISSN: 14777827     Source Type: Journal    
DOI: 10.1186/s12958-015-0124-y     Document Type: Article

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