title: Observational study of the local tolerability of injectable progesterone microspheres.
abstract: BACKGROUND
  As intramuscular progesterone administration is associated with local intolerance, the purpose of this work was to determine the local tolerability of a new progesterone microsphere suspension, administered by intramuscular injection.
  
  
  METHODS
  An observational, longitudinal, prospective, analytical, multicenter, active pharmacovigilance study was conducted. Two hundred and seven progesterone microsphere administrations were evaluated. Patients evaluated pain, burning sensation, pruritus and dysesthesia. Physicians evaluated erythema, pallor, petechia, ecchymosis, bleeding, edema, induration, abscess, macule, papule, vesicle and pustule. Local tolerability was evaluated using a visual analog scale (100-mm line) on the day of administration, and subsequently on days 3 and 7. Local symptoms were evaluated by patients and local signs by the attending physicians.
  
  
  RESULTS
  On the day of application, 68.4% of the administered doses were associated with 'absent' or 'mild' pain, rising to 91.2% on the 7th day; 83.0% of doses were associated with 'absence' of or a 'mild' burning sensation on the day of administration, rising to 99.5% on day 7. On administration day, 13.2% reported 'mild' erythema and 1.0% 'moderate' erythema, and 3.9% of doses had 'mild' induration and 0.5% 'moderate' induration, which increased to 16.6 and 2.9% on day 3, respectively. The values for pallor, ecchymosis, bleeding, edema and pustule were lower than 10 mm (of 100 mm) on the application day and behaved similarly in subsequent days. There were no reports of petechia, abscess, macule, papule or vesicle with the dose application.
  
  
  CONCLUSIONS
  Progesterone microspheres were well tolerated without serious or unexpected adverse effects.
authors: Asociación Mexicana para la Investigación Clínica, A.C., Pachuca, Mexico. rbernardo@techsphere.com.mx
authors: Roberto
authors: R
authors: Bernardo-Escudero
authors: Manuel
authors: M
authors: Cortés-Bonilla
authors: Rosalba
authors: R
authors: Alonso-Campero
authors: María Teresa de Jesús
authors: MT
authors: Francisco-Doce
authors: Juan
authors: J
authors: Chavarín-González
authors: Shantal
authors: S
authors: Pimentel-Martínez
authors: Lucía
authors: L
authors: Zambrano-Tapia
mesh_terms: D000293:Adolescent; D000328:Adult; D016503:Drug Delivery Systems; D004890:Erythema / Q000139:chemically induced; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy*; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007273:Injections, Intramuscular; D008137:Longitudinal Studies; D008863:Microspheres; D019370:Observation; D010147:Pain Measurement; D060735:Pharmacovigilance; D011374:Progesterone / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D011374:Progesterone