title: Dienogest 2 mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis: The VISanne Study to Assess Safety in ADOlescents.
abstract: OBJECTIVE
  To study the safety and efficacy of dienogest 2 mg in adolescents with suspected endometriosis.
  
  
  METHODS
  A 52-week, open-label, single-arm study.
  
  
  METHODS
  In 21 study centers, in 6 European countries.
  
  
  METHODS
  Adolescents aged 12 to younger than 18 years with clinically suspected or laparoscopically confirmed endometriosis.
  
  
  METHODS
  Dienogest 2 mg once daily.
  
  
  METHODS
  The primary end point was relative change in lumbar spine (L2-L4) bone mineral density (BMD) measured using dual-energy x-ray absorptiometry. A key secondary end point was change in endometriosis-associated pain assessed using a visual analogue scale.
  
  
  RESULTS
  Of 120 patients screened, 111 comprised the full-analysis set (ie, patients who took ≥1 dose of study drug and had ≥1 post-treatment observation) and 97 (87.4%) completed the study. Mean lumbar BMD at baseline was 1.1046 (SD, 0.1550) g/cm2. At the end of dienogest treatment (EOT; defined as at 52 weeks or premature study discontinuation), mean relative change in BMD from baseline was -1.2% (SD, 2.3%; n = 103). Follow-up measurement 6 months after EOT in the subgroup with decreased BMD at EOT (n = 60) showed partial recovery in lumbar BMD (mean change from baseline: -2.3% at EOT, -0.6% 6 months after EOT). Mean endometriosis-associated pain score was 64.3 (SD, 19.1) mm at baseline and decreased to 9.0 (SD, 13.9) mm by week 48.
  
  
  CONCLUSIONS
  In adolescents with suspected endometriosis, dienogest 2 mg for 52 weeks was associated with a decrease in lumbar BMD, followed by partial recovery after treatment discontinuation. Endometriosis-associated pain was substantially reduced during treatment. Because bone accretion is critical during adolescence, results of the VISanne study to assess safety in ADOlescents (VISADO) study highlights the need for tailored treatment in this population, taking into account the expected efficacy on endometriosis-associated pain and an individual's risk factors for osteoporosis.
authors.affiliation: Praxis for Women's Health, Gynecology & Obstetrics, Berlin, Germany. Electronic address: info@prof-ebert.de.
authors.forename: Andreas D
authors.initials: AD
authors.lastname: Ebert
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Liying
authors.initials: L
authors.lastname: Dong
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Merz
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Bodo
authors.initials: B
authors.lastname: Kirsch
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Maja
authors.initials: M
authors.lastname: Francuski
authors.affiliation: Department of Gynecologic Endocrinology and Reproductive Medicine, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Bettina
authors.initials: B
authors.lastname: Böttcher
authors.affiliation: Department of Gynecology and Obstetrics, Rouen University Hospital, Rouen, France; Research Group 4308 'Spermatogenesis and Gamete Quality', Reproductive Biology Laboratory, Rouen University Hospital, Rouen, France.
authors.forename: Horace
authors.initials: H
authors.lastname: Roman
authors.affiliation: Department of Obstetrics and Gynecology, University of Turku and Turku University Hospital, Turku, Finland.
authors.forename: Pia
authors.initials: P
authors.lastname: Suvitie
authors.affiliation: Gynaecological Rehabilitation Center, Budějovické předměstí, Písek, Czech Republic.
authors.forename: Olga
authors.initials: O
authors.lastname: Hlavackova
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Gude
authors.affiliation: Bayer AG, Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Seitz
mesh_terms: D015502:Absorptiometry, Photon; D000293:Adolescent; D015519:Bone Density / Q000187:drug effects*; D002648:Child; D004715:Endometriosis / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006727:Hormone Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008159:Lumbar Vertebrae; D009277:Nandrolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010147:Pain Measurement; D017699:Pelvic Pain / Q000188:drug therapy
chemical_list: D006727:Hormone Antagonists; C023635:dienogest; D009277:Nandrolone
keywords: Adolescent; Bone mineral density; Dienogest; Endometriosis; Pelvic pain